Trial Outcomes & Findings for Vitamin D Absorption in HIV Infected Young Adults Being Treated With Tenofovir Containing cART (NCT NCT01751646)

Results Overview

Percent change from baseline to week (wk) 48 in DXA-measured BMD at the spine for the randomized study groups. Lumbar spine BMD (L1 - L4) (g/cm2) change from Baseline to wk 48 visit.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

214 participants

Primary outcome timeframe

Baseline and wk 48

Results posted on

2019-03-27

Participant Flow

This research was conducted at 17 clinical sites, with accrual opening 10/2012. Due to budgetary constraints, accrual to protocol Version 1.0 was placed on hold 9/1/2013; follow-up visits for subjects on study continued while accrual was on hold. Version 2.0 opened to accrual on 2/2/2015. The study was closed to accrual on 6/3/1015.

Participant milestones

Participant milestones
Measure	Group A: Vitamin D3 50,000 IU Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Overall Study STARTED	109	105
Overall Study COMPLETED	98	87
Overall Study NOT COMPLETED	11	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Group A: Vitamin D3 50,000 IU Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Overall Study Lost to Follow-up	5	1
Overall Study Withdrawal by Subject	0	4
Overall Study Starting hormone therapy	1	0
Overall Study Missed 4 or more consecutive DOT visits	2	3
Overall Study Inadvertent enrollment	1	1
Overall Study Moved out of the area	1	5
Overall Study Inability to attend required visits	0	1
Overall Study Off study due to multiple obligations	0	1
Overall Study Fails to comply with study requirements	0	1
Overall Study Childcare issues	1	1

Baseline Characteristics

Subjects with valid DXA data for Total Hip

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A: Vitamin D3 50,000 IU n=108 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=104 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT	Total n=212 Participants Total of all reporting groups
Age, Continuous	21.84 years STANDARD_DEVIATION 1.95 • n=108 Participants	21.85 years STANDARD_DEVIATION 1.55 • n=104 Participants	21.84 years STANDARD_DEVIATION 1.76 • n=212 Participants
Sex: Female, Male Female	18 Participants n=108 Participants	15 Participants n=104 Participants	33 Participants n=212 Participants
Sex: Female, Male Male	90 Participants n=108 Participants	89 Participants n=104 Participants	179 Participants n=212 Participants
Race/Ethnicity, Customized Race · Black	78 Participants n=108 Participants	79 Participants n=104 Participants	157 Participants n=212 Participants
Race/Ethnicity, Customized Race · Non-black	30 Participants n=108 Participants	25 Participants n=104 Participants	55 Participants n=212 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	21 Participants n=108 Participants	24 Participants n=104 Participants	45 Participants n=212 Participants
Race/Ethnicity, Customized Ethnicity · Non-Hispanic or Non-Latino	87 Participants n=108 Participants	79 Participants n=104 Participants	166 Participants n=212 Participants
Race/Ethnicity, Customized Ethnicity · Unknown/Not reported	0 Participants n=108 Participants	1 Participants n=104 Participants	1 Participants n=212 Participants
Season Enrolled Winter	44 Participants n=108 Participants	39 Participants n=104 Participants	83 Participants n=212 Participants
Season Enrolled Spring	43 Participants n=108 Participants	42 Participants n=104 Participants	85 Participants n=212 Participants
Season Enrolled Summer	15 Participants n=108 Participants	18 Participants n=104 Participants	33 Participants n=212 Participants
Season Enrolled Fall	6 Participants n=108 Participants	5 Participants n=104 Participants	11 Participants n=212 Participants
Lumbar spine bone mineral density (BMD)	1.06 g/cm^2 n=108 Participants	1.08 g/cm^2 n=104 Participants	1.07 g/cm^2 n=212 Participants
Lumbar spine BMD (L1-L4) (Z-score)	-0.65 z-score n=108 Participants	-0.70 z-score n=104 Participants	-0.70 z-score n=212 Participants
Total Hip BMD	1.06 g/cm^2 n=107 Participants • Subjects with valid DXA data for Total Hip	1.05 g/cm^2 n=104 Participants • Subjects with valid DXA data for Total Hip	1.06 g/cm^2 n=211 Participants • Subjects with valid DXA data for Total Hip
Total hip BMD (Z-score)	-0.40 Z-score n=105 Participants • Subjects with Total hip BMD z-score data	-0.65 Z-score n=104 Participants • Subjects with Total hip BMD z-score data	-0.50 Z-score n=209 Participants • Subjects with Total hip BMD z-score data
Femoral neck BMD	0.98 g/cm^2 n=107 Participants • Subjects with valid DXA data for Femoral Neck	1.00 g/cm^2 n=104 Participants • Subjects with valid DXA data for Femoral Neck	0.99 g/cm^2 n=211 Participants • Subjects with valid DXA data for Femoral Neck
Femoral neck BMD (Z-score)	-0.50 Z-score n=105 Participants • Subjects with available Femoral Neck z-score for baseline	-0.60 Z-score n=104 Participants • Subjects with available Femoral Neck z-score for baseline	-0.60 Z-score n=209 Participants • Subjects with available Femoral Neck z-score for baseline
Whole Body BMD	1.18 g/cm^2 n=108 Participants	1.17 g/cm^2 n=104 Participants	1.17 g/cm^2 n=212 Participants
Whole body BMD (Z-score)	-0.60 Z-score n=108 Participants	-0.80 Z-score n=104 Participants	-0.70 Z-score n=212 Participants
Whole Body Bone Mineral Content (BMC)	2636.03 g n=108 Participants	2596.06 g n=104 Participants	2627.16 g n=212 Participants
Serum Calcium (SCa)	9.40 mg/dL n=108 Participants	9.34 mg/dL n=104 Participants	9.39 mg/dL n=212 Participants
Urinary Calcium/ Urinary Creatinine ratio (UCa/UCr)	0.04 ratio n=107 Participants • Subjects with Uca/Ucr lab data available	0.04 ratio n=103 Participants • Subjects with Uca/Ucr lab data available	0.04 ratio n=210 Participants • Subjects with Uca/Ucr lab data available
Serum Phosphate (SPO4)	3.56 mg/dL n=108 Participants	3.50 mg/dL n=104 Participants	3.52 mg/dL n=212 Participants
Tubular reabsorption of phosphate (TRP) %	91.72 percent n=107 Participants • Subjects with TRP % lab data available	91.53 percent n=103 Participants • Subjects with TRP % lab data available	91.56 percent n=210 Participants • Subjects with TRP % lab data available
Vitamin D serum concentration (25-(OH)D Total)	15.69 ng/mL n=108 Participants	16.76 ng/mL n=104 Participants	16.37 ng/mL n=212 Participants
C-terminal telopeptides (CTX)	0.76 mcg/L n=108 Participants	0.78 mcg/L n=104 Participants	0.77 mcg/L n=212 Participants
Parathyroid hormone (PTH)	38.72 pg/mL n=107 Participants • Subjects with available data	37.04 pg/mL n=103 Participants • Subjects with available data	37.73 pg/mL n=210 Participants • Subjects with available data
Fibroblast growth factor 23 (FGF23)	33.23 pg/mL n=108 Participants	34.53 pg/mL n=104 Participants	33.99 pg/mL n=212 Participants
Serum 125 dihydroxy vitamin D (125-OHD)	72.54 pg/mL n=107 Participants • Subjects with available data	68.94 pg/mL n=104 Participants • Subjects with available data	71.08 pg/mL n=211 Participants • Subjects with available data
Actual Free 125(OH)D	418.48 fmol/L n=107 Participants • Subjects with available data	445.29 fmol/L n=104 Participants • Subjects with available data	422.91 fmol/L n=211 Participants • Subjects with available data
Serum Creatinine (SCr)	0.89 mg/dL n=108 Participants	0.86 mg/dL n=104 Participants	0.86 mg/dL n=212 Participants
Estimated glomerular filtration rate (eGFR)	125.02 ml/min/1.73m^2 n=108 Participants	125.62 ml/min/1.73m^2 n=104 Participants	125.03 ml/min/1.73m^2 n=212 Participants
Urine Glucose (UGluc)	7.16 mg/dL n=108 Participants	7.40 mg/dL n=104 Participants	7.27 mg/dL n=212 Participants
Urine retinol binding protein (URBP)/ Urine creatinine (UCr)	101.21 mcg/g n=107 Participants • Subjects with available data	104.00 mcg/g n=102 Participants • Subjects with available data	101.21 mcg/g n=209 Participants • Subjects with available data
Urine beta-2 microglobulin (UB2MG)	111.17 mcg/L n=107 Participants • Subjects with available data	134.08 mcg/L n=101 Participants • Subjects with available data	127.95 mcg/L n=208 Participants • Subjects with available data
Urine protein (UProt) / Urine creatinine (UCr)	0.07 ratio n=107 Participants • Subjects with available data	0.07 ratio n=103 Participants • Subjects with available data	0.07 ratio n=210 Participants • Subjects with available data
Bone specific alkaline phosphatase (BAP)	31.49 U/L n=108 Participants	31.76 U/L n=104 Participants	31.62 U/L n=212 Participants
Osteocalcin (OC)	9.60 mcg/L n=108 Participants	8.94 mcg/L n=104 Participants	9.21 mcg/L n=212 Participants
Glucose Homeostasis (Fasting insulin)	8.87 uIU/mL n=108 Participants • Subjects with available data	8.69 uIU/mL n=103 Participants • Subjects with available data	8.70 uIU/mL n=211 Participants • Subjects with available data
Glucose Homeostasis (Fasting glucose)	85.55 mg/dL n=107 Participants • Subjects with available data	86.55 mg/dL n=103 Participants • Subjects with available data	85.68 mg/dL n=210 Participants • Subjects with available data
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)	1.86 units on a scale n=107 Participants • Subjects with available data	1.78 units on a scale n=102 Participants • Subjects with available data	1.85 units on a scale n=209 Participants • Subjects with available data

PRIMARY outcome

Timeframe: Baseline and wk 48

Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be greater than the number completed in the Participant Flow section.

Percent change from baseline to week (wk) 48 in DXA-measured BMD at the spine for the randomized study groups. Lumbar spine BMD (L1 - L4) (g/cm2) change from Baseline to wk 48 visit.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=99 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=89 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Percent Change From Baseline to Week 48 in Dual Energy X-ray Absorptiometry (DXA)-Measured BMD at the Spine for the Randomized Study Groups	0.19 percent change Interval -1.54 to 1.48	0.09 percent change Interval -1.49 to 2.61

SECONDARY outcome

Timeframe: Baseline and week 24

Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be greater than the number completed in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=103 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=98 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Percent Change From Baseline to Week 24 of BMC of Whole Body for the Randomized Study Groups	0.25 percent change Interval -1.23 to 1.44	0.07 percent change Interval -0.82 to 1.09

SECONDARY outcome

Timeframe: Baseline and week 48

Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=99 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=89 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Percent Change From Baseline to Week 48 of BMC of Whole Body for the Randomized Study Groups	0.08 percent change Interval -1.47 to 1.47	0.07 percent change Interval -1.47 to 0.98

SECONDARY outcome

Timeframe: Baseline and week 24

Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=103 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=98 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Percent Change From Baseline to Week 24 of Lumbar Spine (L1-L4) BMD for the Randomized Study Groups	0.94 percent change Interval -0.72 to 2.16	0.42 percent change Interval -1.02 to 1.91

SECONDARY outcome

Timeframe: Baseline and week 24

Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.

The Z-score is the standard deviation around mean bone mineral density in the lumbar spine, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=103 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=98 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 24 of Lumbar Spine (L1-L4) BMD Z-score for the Randomized Study Groups	0.00 z-score Interval -0.1 to 0.2	0.00 z-score Interval -0.1 to 0.1

SECONDARY outcome

Timeframe: Baseline and week 48

Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.

The Z-score is the standard deviation around mean bone mineral density in the lumbar spine, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=99 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=89 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 48 of Lumbar Spine (L1-L4) BMD Z-score for the Randomized Study Groups	0.00 z-score Interval -0.1 to 0.1	-0.10 z-score Interval -0.3 to 0.2

SECONDARY outcome

Timeframe: Baseline and week 24

Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=103 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=98 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Percent Change From Baseline to Week 24 of Femoral Neck BMD for the Randomized Study Groups	-0.10 percent change Interval -2.49 to 1.65	-0.04 percent change Interval -2.16 to 2.13

SECONDARY outcome

Timeframe: Baseline and week 48

Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=99 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=89 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Percent Change From Baseline to Week 48 of Femoral Neck BMD for the Randomized Study Groups	-0.30 percent change Interval -2.63 to 1.73	-0.11 percent change Interval -2.45 to 1.96

SECONDARY outcome

Timeframe: Baseline and week 24

Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.

The Z-score is the standard deviation around mean bone mineral density in the femoral neck, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=103 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=98 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 24 of Femoral Neck BMD Z-score for the Randomized Study Groups	0.00 z-score Interval -0.2 to 0.1	0.00 z-score Interval -0.1 to 0.2

SECONDARY outcome

Timeframe: Baseline and week 48

Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.

The Z-score is the standard deviation around mean bone mineral density in the femoral neck, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=97 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=89 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 48 of Femoral Neck BMD Z-score for the Randomized Study Groups	0.00 z-score Interval -0.2 to 0.1	0.00 z-score Interval -0.2 to 0.1

SECONDARY outcome

Timeframe: Baseline and week 24

Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=103 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=98 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Percent Change From Baseline to Week 24 of Total Hip BMD for the Randomized Study Groups	-0.27 percent change Interval -1.08 to 1.53	0.00 percent change Interval -1.14 to 1.46

SECONDARY outcome

Timeframe: Baseline and week 48

Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=99 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=89 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Percent Change From Baseline to Week 48 of Total Hip BMD for the Randomized Study Groups	-0.17 percent change Interval -2.12 to 1.73	-0.42 percent change Interval -1.66 to 0.71

SECONDARY outcome

Timeframe: Baseline and week 24

Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.

The Z-score is the standard deviation around mean bone mineral density in the total hip, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=101 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=98 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 24 of Total Hip BMD Z-score for the Randomized Study Groups	0.00 z-score Interval -0.1 to 0.1	0.00 z-score Interval -0.1 to 0.1

SECONDARY outcome

Timeframe: Baseline and week 48

Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.

The Z-score is the standard deviation around mean bone mineral density in the total hip, adjusted for sex, age, and race/ethnicity. An average Z-score of zero would be expected to be seen in healthy populations. A negative Z-score indicates lower than average bone mineral density. Low bone mineral density is a frequent finding in HIV-infected individuals, including adolescents and young adults.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=97 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=89 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 48 of Total Hip BMD Z-score for the Randomized Study Groups	0.00 z-score Interval -0.1 to 0.1	0.00 z-score Interval -0.1 to 0.1

SECONDARY outcome

Timeframe: Baseline and week 12

Population: Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

To assess renal glomerular safety by measuring change in SCr from baseline to week 12 by randomized study group;

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=106 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=100 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change in SCr From Baseline to Week 12.	0.03 mg/dL Interval -0.03 to 0.08	0.02 mg/dL Interval -0.03 to 0.07

SECONDARY outcome

Timeframe: Baseline and week 24

Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

To assess renal glomerular safety by measuring change in SCr from baseline to week 24 by randomized study group;

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=103 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=98 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change in SCr From Baseline to Week 24.	0.02 mg/dL Interval -0.03 to 0.08	0.02 mg/dL Interval -0.04 to 0.06

SECONDARY outcome

Timeframe: Baseline and week 48

Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.

To assess renal glomerular safety by measuring change in SCr from baseline to week 48 by randomized study group;

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=100 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=91 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change in SCr From Baseline to Week 48.	0.03 mg/dL Interval -0.02 to 0.08	0.01 mg/dL Interval -0.03 to 0.07

SECONDARY outcome

Timeframe: Baseline and 48 weeks

Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=99 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=89 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 48 in Glucose Homeostasis (Fasting Insulin)	0.45 uIU/mL Interval -2.21 to 3.48	-0.83 uIU/mL Interval -3.02 to 3.43

SECONDARY outcome

Timeframe: Baseline and week 48

Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=99 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=90 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 48 in Glucose Homeostasis (Fasting Glucose)	0.05 mg/dL Interval -5.05 to 4.2	-0.20 mg/dL Interval -4.85 to 3.85

SECONDARY outcome

Timeframe: Baseline and week 48

Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.

HOMA-IR is calculated as fasting glucose (mg/dL) X fasting glucose (uIU/mL) / 405. An increase in HOMA-IR means that an individual has become more resistant (less sensitive) to the effects of insulin and thus would be a negative outcome. A reduction in HOMA-IR means that an individual has become more sensitive to the effects of insulin and would be considered a positive outcome.There are no set minimum or maximum scores for HOMA-IR, since it is based on measurements of insulin and glucose, the assays for which may vary. Several studies suggest a cut-off of \>2 for any insulin resistance, but "normal" values appear to vary greatly by population (https://www.mdcalc.com/homa-ir-homeostatic-model-assessment-insulin-resistance).

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=98 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=88 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 48 in Glucose Homeostasis (Homeostasis Model Assessment of Insulin Resistance (HOMA-IR))	0.07 units on a scale Interval -0.56 to 0.82	-0.15 units on a scale Interval -0.8 to 0.83

SECONDARY outcome

Timeframe: Baseline and wk 12

Population: Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=106 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=100 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 12 in Serum Calcium (SCa)	-0.02 mg/dL Interval -0.26 to 0.2	0.08 mg/dL Interval -0.14 to 0.25

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=103 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=98 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 24 in Serum Calcium (SCa)	-0.04 mg/dL Interval -0.26 to 0.16	0.08 mg/dL Interval -0.16 to 0.3

SECONDARY outcome

Timeframe: Baseline and wk 48

Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=100 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=91 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 48 in Serum Calcium (SCa)	0.00 mg/dL Interval -0.22 to 0.25	0.04 mg/dL Interval -0.12 to 0.26

SECONDARY outcome

Timeframe: Baseline and week 12

Population: Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=106 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=100 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 12 in CTX	-0.03 mcg/L Interval -0.21 to 0.13	-0.02 mcg/L Interval -0.19 to 0.15

SECONDARY outcome

Timeframe: Baseline and week 24

Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=103 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=98 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 24 in CTX	-0.03 mcg/L Interval -0.24 to 0.18	-0.02 mcg/L Interval -0.16 to 0.15

SECONDARY outcome

Timeframe: Baseline and week 48

Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=99 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=91 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 48 in CTX	-0.08 mcg/L Interval -0.25 to 0.1	-0.09 mcg/L Interval -0.27 to 0.02

SECONDARY outcome

Timeframe: Baseline and week 12

Population: Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=106 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=100 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 12 in OC	0.15 mcg/L Interval -0.78 to 1.67	-0.10 mcg/L Interval -1.15 to 1.66

SECONDARY outcome

Timeframe: Baseline and week 24

Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the number completed in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=103 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=98 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 24 in OC	0.09 mcg/L Interval -1.06 to 1.46	-0.22 mcg/L Interval -1.43 to 1.12

SECONDARY outcome

Timeframe: Baseline and wk 48

Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=100 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=90 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 48 in OC	-0.93 mcg/L Interval -2.1 to 0.62	-0.48 mcg/L Interval -1.95 to 0.41

SECONDARY outcome

Timeframe: Baseline and wk 12

Population: Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=106 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=100 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 12 in BAP	-1.05 U/L Interval -4.33 to 1.85	-1.74 U/L Interval -3.82 to 0.88

SECONDARY outcome

Timeframe: Baseline and wk 24

Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=103 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=98 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 24 in BAP	-2.54 U/L Interval -5.31 to 0.07	-2.03 U/L Interval -4.5 to 0.35

SECONDARY outcome

Timeframe: Baseline and wk 48

Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=100 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=91 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 48 in BAP	-2.71 U/L Interval -6.44 to -0.51	-2.19 U/L Interval -5.58 to 1.06

SECONDARY outcome

Timeframe: Baseline and wk 12

Population: Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=106 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=100 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 12 in FGF23	3.31 pg/ML Interval -2.99 to 9.21	3.90 pg/ML Interval -2.28 to 9.21

SECONDARY outcome

Timeframe: Baseline and wk 24

Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=103 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=98 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 24 in FGF23	2.93 pg/ML Interval -4.07 to 8.35	3.65 pg/ML Interval -4.45 to 10.53

SECONDARY outcome

Timeframe: Baseline and wk 48

Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=100 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=91 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 48 in FGF23	4.77 pg/ML Interval -2.78 to 10.31	3.15 pg/ML Interval -3.75 to 10.15

SECONDARY outcome

Timeframe: Baseline and wk 12

Population: Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=105 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=99 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 12 in PTH	-2.17 pg/ML Interval -10.26 to 4.0	-0.82 pg/ML Interval -7.79 to 3.95

SECONDARY outcome

Timeframe: Baseline and wk 24

Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=101 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=96 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 24 in PTH	-0.25 pg/ML Interval -10.38 to 6.7	-1.71 pg/ML Interval -7.78 to 5.65

SECONDARY outcome

Timeframe: Baseline and wk 48

Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=98 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=89 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 48 in PTH	-2.21 pg/ML Interval -10.13 to 4.25	-0.96 pg/ML Interval -9.28 to 4.93

SECONDARY outcome

Timeframe: Baseline and wk 12

Population: Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Vitamin D serum concentration (1,25 (OH)DTotal) (pmol/L) multiplied by F times 1,000, where F is defined as F = 1/(1 + Kd \* \[VDBP\] + Ka \*\[albumin\]) where the binding constant for VDBP = Kd = 4.2 x 107 M-1, and for albumin is Ka = 5.4 x 104 M-1 and the concentrations of VDBP and albumin are in moles/L

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=105 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=99 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 12 in Actual Free 1,25-OHD	106.50 fmol/L Interval -12.5 to 222.13	53.23 fmol/L Interval -28.51 to 148.88

SECONDARY outcome

Timeframe: Baseline and wk 24

Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Vitamin D serum concentration (1,25 (OH)DTotal) (pmol/L) multiplied by F times 1,000, where F is defined as F = 1/(1 + Kd \* \[VDBP\] + Ka \*\[albumin\]) where the binding constant for VDBP = Kd = 4.2 x 107 M-1, and for albumin is Ka = 5.4 x 104 M-1 and the concentrations of VDBP and albumin are in moles/L

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=101 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=98 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 24 in Actual Free 1,25-OHD	98.61 fmol/L Interval -29.77 to 242.62	59.36 fmol/L Interval -41.94 to 162.45

SECONDARY outcome

Timeframe: Baseline and wk 48

Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Vitamin D serum concentration (1,25 (OH)DTotal) (pmol/L) multiplied by F times 1,000, where F is defined as F = 1/(1 + Kd \* \[VDBP\] + Ka \*\[albumin\]) where the binding constant for VDBP = Kd = 4.2 x 107 M-1, and for albumin is Ka = 5.4 x 104 M-1 and the concentrations of VDBP and albumin are in moles/L

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=99 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=91 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 48 in Actual Free 1,25-OHD	63.73 fmol/L Interval -19.39 to 202.54	25.66 fmol/L Interval -100.82 to 118.45

SECONDARY outcome

Timeframe: Baseline and wk 12

Population: Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=105 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=100 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 12 in 1,25-OHD	15.61 pg/ML Interval -0.32 to 35.18	6.06 pg/ML Interval -7.63 to 25.52

SECONDARY outcome

Timeframe: Baseline and wk 24

Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=102 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=98 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 24 in 1,25-OHD	12.90 pg/ML Interval -7.57 to 36.58	8.58 pg/ML Interval -8.96 to 27.02

SECONDARY outcome

Timeframe: Baseline and wk 48

Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=99 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=91 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 48 in 1,25-OHD	10.52 pg/ML Interval -2.05 to 31.47	2.74 pg/ML Interval -14.73 to 24.48

SECONDARY outcome

Timeframe: Baseline and wk 12

Population: Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=106 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=100 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 12 in 25-OHD	16.33 ng/ML Interval 9.33 to 21.19	6.91 ng/ML Interval 2.34 to 11.55

SECONDARY outcome

Timeframe: Baseline and wk 24

Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=103 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=98 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 24 in 25-OHD	18.60 ng/ML Interval 10.53 to 25.58	6.78 ng/ML Interval 1.35 to 11.24

SECONDARY outcome

Timeframe: Baseline and wk 48

Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=100 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=91 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 48 in 25-OHD	17.80 ng/ML Interval 11.83 to 24.03	2.64 ng/ML Interval -1.66 to 7.52

SECONDARY outcome

Timeframe: Baseline and wk 12

Population: Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=105 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=98 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 12 in TRP %	-0.71 percent Interval -3.46 to 2.03	0.04 percent Interval -2.78 to 3.37

SECONDARY outcome

Timeframe: Baseline and wk 24

Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=101 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=95 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 24 in TRP %	-0.59 percent Interval -4.43 to 1.79	-0.88 percent Interval -3.001 to 2.32

SECONDARY outcome

Timeframe: Baseline and wk 48

Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=98 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=87 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 48 in TRP %	-1.55 percent Interval -4.71 to 1.84	0.62 percent Interval -2.92 to 3.06

SECONDARY outcome

Timeframe: Baseline and wk 12

Population: Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=106 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=100 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 12 in SPO4	0.00 mg/dL Interval -0.34 to 0.26	0.02 mg/dL Interval -0.33 to 0.38

SECONDARY outcome

Timeframe: Baseline and wk 24

Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=103 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=98 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 24 in SPO4	-0.06 mg/dL Interval -0.42 to 0.29	0.03 mg/dL Interval -0.34 to 0.34

SECONDARY outcome

Timeframe: Baseline and wk 48

Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=100 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=91 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 48 in SPO4	-0.03 mg/dL Interval -0.33 to 0.36	-0.12 mg/dL Interval -0.47 to 0.31

SECONDARY outcome

Timeframe: Baseline and wk 12

Population: Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=105 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=98 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 12 in UCa/Ucr	0.00 ratio Interval -0.02 to 0.04	0.00 ratio Interval -0.01 to 0.04

SECONDARY outcome

Timeframe: Baseline and wk 24

Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=101 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=95 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 24 in UCa/Ucr	0.01 ratio Interval -0.01 to 0.05	0.01 ratio Interval -0.01 to 0.02

SECONDARY outcome

Timeframe: Baseline and wk 48

Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=98 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=87 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change From Baseline to Week 48 in UCa/Ucr	0.00 ratio Interval -0.01 to 0.03	0.01 ratio Interval -0.01 to 0.04

SECONDARY outcome

Timeframe: Baseline and wk 12

Population: Subjects who had baseline and wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

To assess renal glomerular safety by measuring change in estimated GFR from baseline to week 12 by randomized study group. eGFR calculated by the CKD-Epi equation for subjects \>=18 years of age, and by bedside Schwartz formula for subjects \<18 years of age

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=106 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=100 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change in Estimated GFR From Baseline to Week 12.	0.00 ml/min/1.73m^2 Interval -12.11 to 6.29	0.00 ml/min/1.73m^2 Interval -7.49 to 7.18

SECONDARY outcome

Timeframe: Baseline and wk 24

Population: Subjects who had baseline and wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

To assess renal glomerular safety by measuring change in estimated GFR from baseline to week 24 by randomized study group;

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=103 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=98 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change in Estimated GFR From Baseline to Week 24.	0.00 ml/min/1.73m^2 Interval -15.24 to 2.43	0.00 ml/min/1.73m^2 Interval -10.42 to 7.71

SECONDARY outcome

Timeframe: Baseline and wk 48

Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

To assess renal glomerular safety by measuring change in estimated GFR from baseline to week 48 by randomized study group;

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=100 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=91 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change in Estimated GFR From Baseline to Week 48.	-1.91 ml/min/1.73m^2 Interval -15.67 to 3.7	0.00 ml/min/1.73m^2 Interval -10.96 to 5.65

SECONDARY outcome

Timeframe: Baseline and wk 48

Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

To assess renal tubular function by measuring change in urine glucose (UGluc) by randomized study group;

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=100 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=91 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change in UGluc From Baseline to Week 48	-0.42 mg/dL Interval -3.27 to 3.23	-0.43 mg/dL Interval -3.17 to 2.62

SECONDARY outcome

Timeframe: Baseline and wk 48

Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

To assess renal tubular function by measuring change in urine retinol binding protein to urine creatinine (URBP/UCr) ratio by randomized study group;

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=98 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=88 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change in URBP/UCr Ratio From Baseline to Week 48	-1.06 mcg/g Interval -37.77 to 32.56	-4.72 mcg/g Interval -33.97 to 18.15

SECONDARY outcome

Timeframe: Baseline and wk 48

Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

To assess renal tubular function by measuring change in urine beta-2 microglobulin (UB2MG) by randomized study group;

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=98 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=89 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change in UB2MG From Baseline to Week 48	5.19 mcg/L Interval -95.04 to 111.85	10.75 mcg/L Interval -90.69 to 157.26

SECONDARY outcome

Timeframe: Baseline and wk 48

Population: Subjects who had baseline and wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

To assess renal tubular function by measuring change in urinary protein to creatinine ratio by randomized study group;

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=98 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=90 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Change in UProt/ UCr Ratio From Baseline to Week 48	0.00 ratio Interval -0.02 to 0.01	0.00 ratio Interval -0.01 to 0.01

SECONDARY outcome

Timeframe: Week 12

Population: Subjects who had wk 12 data. This includes subjects enrolled in v1.0, who completed wk 12 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=106 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=100 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
25-OHD Serum Concentration by Randomized Study Group at Week 12	35.14 ng/mL Interval 29.79 to 39.76	23.97 ng/mL Interval 18.35 to 30.19

SECONDARY outcome

Timeframe: Week 24

Population: Subjects who had wk 24 data. This includes subjects enrolled in v1.0, who completed wk 24 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=103 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=98 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
25-OHD Serum Concentration by Randomized Study Group at Week 24	37.04 ng/mL Interval 30.41 to 44.12	23.30 ng/mL Interval 17.92 to 28.49

SECONDARY outcome

Timeframe: Week 48

Population: Subjects who had wk 48 data. This includes subjects enrolled in v1.0, who completed wk 48 evaluations, but were prematurely discontinued before the wk 96 or Post-wk 48 visits and therefore not counted as having completed the study. Thus, the number analyzed may be different from the numbers in the Participant Flow section.

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=100 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=91 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
25-OHD Serum Concentration by Randomized Study Group at Week 48	36.89 ng/mL Interval 30.46 to 42.38	20.55 ng/mL Interval 14.35 to 25.8

SECONDARY outcome

Timeframe: Baseline

Population: Authors were interested in comparing mean 25-OHD at baseline by those who used efavirenz vs those who did not use efavirenz; a separate analysis by treatment arm was not done. Due to different comparison groups, the number of subjects analyzed differ from the numbers in the Participant Flow section.

Mean Vitamin D serum concentration (25-(OH)D) Total) in those with efavirenz use vs. those without efavirenz use

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=78 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=134 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Concentration at Baseline by Efavirenz Use	17.02 ng/mL Standard Deviation 8.69	19.61 ng/mL Standard Deviation 9.96

SECONDARY outcome

Timeframe: Week 48

Population: Authors were interested in comparing mean 25-OHD at wk 48 by those who used efavirenz vs those who did not use efavirenz; a separate analysis by treatment arm was not done. Due to different comparison groups, the number of subjects analyzed differ from the numbers in the Participant Flow section.

Mean Vitamin D serum concentration (25-(OH)D) Total) in those with efavirenz use vs. those without efavirenz use

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=72 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=119 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Concentration at Week 48 by Efavirenz Use	28.24 ng/mL Standard Deviation 11.22	29.68 ng/mL Standard Deviation 11.52

SECONDARY outcome

Timeframe: Baseline and wk 48

Population: Authors were interested in comparing the change in mean 25-OHD from baseline to wk 48 by those who used efavirenz vs those who did not use efavirenz; a separate analysis by treatment arm was not done. Due to different comparison groups, the number of subjects analyzed differ from the numbers in the Participant Flow section.

Mean Vitamin D serum concentration (25-(OH)D) Total) in those with efavirenz use vs. those without efavirenz use

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=72 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=119 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Effect of Concurrent Treatment With Efavirenz on 25-OHD Serum Concentration: Change in Concentration From Baseline to Week 48 by Efavirenz Use	10.97 ng/mL Standard Deviation 12.00	9.79 ng/mL Standard Deviation 11.68

SECONDARY outcome

Timeframe: Baseline

Population: Authors were interested in comparing mean 25-OHD at baseline by those who used ritonavir vs those who did not use ritonavir; a separate analysis by treatment arm was not done. Due to different comparison groups, the number of subjects analyzed differ from the numbers in the Participant Flow section.

Mean Vitamin D serum concentration (25-(OH)D) Total) in those with ritonavir use vs. those without ritonavir use

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=88 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=124 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Concentration at Baseline by Ritonavir Use	18.62 ng/mL Standard Deviation 8.79	18.69 ng/mL Standard Deviation 10.13

SECONDARY outcome

Timeframe: Week 48

Population: Authors were interested in comparing mean 25-OHD at wk 48 by those who used ritonavir vs those who did not use ritonavir; a separate analysis by treatment arm was not done. Due to different comparison groups, the number of subjects analyzed differ from the numbers in the Participant Flow section.

Mean Vitamin D serum concentration (25-(OH)D) Total) in those with ritonavir use vs. those without ritonavir use

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=77 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=114 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Concentration at Week 48 by Ritonavir Use	29.46 ng/mL Standard Deviation 10.70	28.92 ng/mL Standard Deviation 11.89

SECONDARY outcome

Timeframe: Baseline and wk 48

Population: Authors were interested in comparing the change in mean 25-OHD from baseline to wk 48 by those who used ritonavir vs those who did not use ritonavir; a separate analysis by treatment arm was not done. Due to different comparison groups, the number of subjects analyzed differ from the numbers in the Participant Flow section.

Mean Vitamin D serum concentration (25-(OH)D) Total) in those with ritonavir use vs. those without ritonavir use

Outcome measures

Outcome measures
Measure	Group A: Vitamin D3 50,000 IU n=77 Participants Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=114 Participants Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Effect of Concurrent Treatment With Ritonavir on 25-OHD Serum Concentration: Change in Concentration From Baseline to Week 48 by Ritonavir Use	10.55 ng/mL Standard Deviation 11.07	10.02 ng/mL Standard Deviation 12.28

Adverse Events

Group A: Vitamin D3 50,000 IU

Serious events: 5 serious events

Other events: 6 other events

Deaths: 0 deaths

Group B: Vitamin D3 Placebo

Serious events: 6 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group A: Vitamin D3 50,000 IU n=109 participants at risk Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=105 participants at risk Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Psychiatric disorders Suicide attempt	0.92% 1/109 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.00% 0/105 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Psychiatric disorders Mental Status Changes	0.92% 1/109 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.00% 0/105 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Psychiatric disorders Acute psychosis	0.00% 0/109 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.95% 1/105 • Number of events 2 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Psychiatric disorders Suicidal ideation	0.00% 0/109 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	1.9% 2/105 • Number of events 2 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Infections and infestations Cellulitis	0.00% 0/109 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	1.9% 2/105 • Number of events 2 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Infections and infestations Cellulitis Streptococcal	0.00% 0/109 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.95% 1/105 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Respiratory, thoracic and mediastinal disorders Asthma	0.92% 1/109 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.00% 0/105 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Infections and infestations Tooth abscess	0.92% 1/109 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.00% 0/105 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Infections and infestations Gastroenteritis	0.92% 1/109 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.00% 0/105 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.

Other adverse events

Additional Information

Dr. Bob Harris

Westat

Phone: 301-251-1500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Adolescent Medicine Trials Network (ATN) for HIV/AIDS Interventions Publication Policy outlines procedures for the development and review of abstracts, publications, and presentations. The Adolescent Medicine Leadership Group (AMLG) retains custody of and primary rights to the data. Use of data must be approved by the protocol team and AMLG.
Publication restrictions are in place

Restriction type: OTHER

Measure	Group A: Vitamin D3 50,000 IU n=109 participants at risk Subjects randomized to Group A will receive Vitamin D3 50,000 IU orally every four weeks by directly observed therapy (DOT). In addition all subjects receive a multivitamin (MVI) that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Calcium (Ca). Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 50,000 IU: Group A: Vitamin D3 50,000 IU orally every four weeks by DOT	Group B: Vitamin D3 Placebo n=105 participants at risk Subjects randomized to Group B will receive Vitamin D3 placebo orally every four weeks by DOT. In addition all subjects receive a MVI that contains ingredients not to exceed 600 IU of vitamin D3 and 200 mg of Ca. Subjects will self-administer one MVI tablet orally once daily. Vitamin D3 placebo: Group B: Vitamin D3 placebo orally every four weeks by DOT
Gastrointestinal disorders Colitis	1.8% 2/109 • Number of events 2 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.00% 0/105 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Gastrointestinal disorders Proctitis	0.92% 1/109 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.00% 0/105 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Infections and infestations Gastroenteritis	0.92% 1/109 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.00% 0/105 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Injury, poisoning and procedural complications Head injury	0.00% 0/109 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.95% 1/105 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Injury, poisoning and procedural complications Laceration	0.00% 0/109 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.95% 1/105 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/109 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.95% 1/105 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Injury, poisoning and procedural complications Tendon Rupture	0.00% 0/109 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.95% 1/105 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Investigations Alanine Aminotransferase Increased	0.00% 0/109 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.95% 1/105 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Investigations Aspartate Aminotransferase Increased	0.00% 0/109 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.95% 1/105 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Investigations Blood Bilirubin Increased	0.00% 0/109 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.95% 1/105 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Investigations Blood Creatinine Increased	0.92% 1/109 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.95% 1/105 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Investigations Blood Glucose Increased	0.00% 0/109 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.95% 1/105 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Investigations Streptococcus Test	0.00% 0/109 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.95% 1/105 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Investigations White Blood Cell Count Increased	0.00% 0/109 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.95% 1/105 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Metabolism and nutrition disorders Decreased Appetite	0.92% 1/109 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.00% 0/105 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Metabolism and nutrition disorders Diabetes Mellitus	0.00% 0/109 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.95% 1/105 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Metabolism and nutrition disorders Hypocalcaemia	0.92% 1/109 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.00% 0/105 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Metabolism and nutrition disorders Hypokalaemia	0.92% 1/109 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.00% 0/105 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/109 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.95% 1/105 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/109 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.95% 1/105 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Psychiatric disorders Suicidal Ideation	0.92% 1/109 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.00% 0/105 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Renal and urinary disorders Hydronephrosis	0.00% 0/109 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.95% 1/105 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Renal and urinary disorders Nephrolithiasis	0.00% 0/109 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.95% 1/105 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/109 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.95% 1/105 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.
Vascular disorders Hypertension	0.00% 0/109 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.	0.95% 1/105 • Number of events 1 • Adverse events were collected between Baseline through Week 48 or premature discontinuation from study.