Trial Outcomes & Findings for Vitamin D Supplementation in HIV Youth (NCT NCT01523496)

Last Updated: 2018-03-08

Results Overview

Evaluate the dose-related efficacy of correction of Vitamin D deficiency for 25(OH)D3 levels in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral Vitamin D supplementation: control dose (18,000 IU per month) or supplemented dose (medium 60,000IU per month or high dose 120,000IU/month )

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

190 participants

Primary outcome timeframe

6 months

Results posted on

2018-03-08

Participant Flow

Participant milestones

Participant milestones
Measure	HIV+ With Vit D Supplementation HIV-infected adults who were supplemented with vit D ( medium dose: 60,000 IU per month or vitamin D high dose: 120,000 IU/month ) were combined into the supplementation group and compared to the standard control vitamin D dose	HIV+ Young Adults With Vitamin D Control Dose HIV+ receiving Vitamin D low dose: 18,000 IU per month	HIV - With Vitamin D Supplementation HIV-uninfected adults who were supplemented with vitamin D: a medium dose of 60,000 IU per month or a higher dose of 120,000 IU/month.	HIV - With Vitamin D Control Dose HIV uninfected controls receiving Vitamin D low dose: 18,000 IU per month
Overall Study STARTED	66	36	58	30
Overall Study COMPLETED	56	32	46	27
Overall Study NOT COMPLETED	10	4	12	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vitamin D Supplementation in HIV Youth

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HIV+ With Vit D Supplementation n=66 Participants HIV-infected adults who were supplemented with vit D ( medium dose: 60,000 IU per month or vitamin D high dose: 120,000 IU/month ) were combined into the supplementation group and compared to the standard control vitamin D dose	HIV+ Young Adults With Vitamin D Control Dose n=36 Participants HIV+ receiving Vitamin D low dose: 18,000 IU per month	HIV - With Vitamin D Supplementation n=58 Participants HIV-uninfected adults who were supplemented with vitamin D: a medium dose of 60,000 IU per month or a higher dose of 120,000 IU/month.	HIV - With Vitamin D Control Dose n=30 Participants HIV uninfected controls receiving Vitamin D low dose: 18,000 IU per month	Total n=190 Participants Total of all reporting groups
Age, Continuous	20.9 years n=93 Participants	19.9 years n=4 Participants	19.6 years n=27 Participants	18.4 years n=483 Participants	19.9 years n=36 Participants
Sex: Female, Male Female	22 Participants n=93 Participants	15 Participants n=4 Participants	20 Participants n=27 Participants	15 Participants n=483 Participants	72 Participants n=36 Participants
Sex: Female, Male Male	44 Participants n=93 Participants	21 Participants n=4 Participants	38 Participants n=27 Participants	15 Participants n=483 Participants	118 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Black or African American	57 Participants n=93 Participants	34 Participants n=4 Participants	47 Participants n=27 Participants	29 Participants n=483 Participants	167 Participants n=36 Participants
Race (NIH/OMB) White	9 Participants n=93 Participants	2 Participants n=4 Participants	11 Participants n=27 Participants	1 Participants n=483 Participants	23 Participants n=36 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Region of Enrollment United States	66 participants n=93 Participants	36 participants n=4 Participants	58 participants n=27 Participants	30 participants n=483 Participants	190 participants n=36 Participants

PRIMARY outcome

Timeframe: 6 months

Population: HIV-infected on vitamin D control or supplementation dose and matched HIV-uninfected group on control or supplementation dose

Outcome measures

Outcome measures
Measure	HIV Positive on Vit D Control Dose n=32 Participants HIV+ receiving low vitamin D dose 18,000 IU per month	HIV Positive on Vit D Supplementation Dose n=56 Participants HIV-infected young adults receiving a supplementation dose of vitamin D (either medium dose of 60,000 IU per month or a high dose of 120,000 IU/month)	HIV Negative on Vitamin D Control Dose n=27 Participants HIV negative controls receiving Vitamin D low dose: 18,000 IU per month	HIV Negative on Vitamin D Supplementation Dose n=46 Participants HIV negative controls receiving Vitamin D medium dose: 60,000 IU per month or vitamin D high dose: 120,000 IU/month
Changes in Serum 25(OH)D3 Levels	11 ng/mL Interval 6.0 to 20.0	22 ng/mL Interval 14.0 to 32.0	7.5 ng/mL Interval 4.0 to 13.0	25 ng/mL Interval 15.0 to 35.0

SECONDARY outcome

Timeframe: 6 months

Population: HIV-infected children and young adults and matched healthy control group. Results were not analyzed were captured comparing HIV+ young adults on control or supplementation vit D to HIV - controls

Evaluate the dose-related efficacy of vitamin D binding Protein in levels in the blood in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral vitamin D supplementation.

Outcome measures

Outcome measures
Measure	HIV Positive on Vit D Control Dose n=32 Participants HIV+ receiving low vitamin D dose 18,000 IU per month	HIV Positive on Vit D Supplementation Dose n=56 Participants HIV-infected young adults receiving a supplementation dose of vitamin D (either medium dose of 60,000 IU per month or a high dose of 120,000 IU/month)	HIV Negative on Vitamin D Control Dose n=27 Participants HIV negative controls receiving Vitamin D low dose: 18,000 IU per month	HIV Negative on Vitamin D Supplementation Dose n=46 Participants HIV negative controls receiving Vitamin D medium dose: 60,000 IU per month or vitamin D high dose: 120,000 IU/month
Changes in Vitamin D Binding Protein (VDBP)	3.9 ng/mL Interval -17.9 to 12.0	-8.9 ng/mL Interval -41.3 to 13.3	-11.3 ng/mL Interval -202.0 to 5.4	-11.7 ng/mL Interval -183.6 to -2.5

Adverse Events

HIV + on Vitamin D Control Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HIV+ on Vitamin D Supplementation Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HIV - on Vitamin D Control Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HIV- on Vitamin D Supplementation Dose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Grace McComsey

University Hospitals Cleveland Medical Center

Phone: 216-844-2739

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place