Trial Outcomes & Findings for The Effects of Vitamin D Repletion in Vitamin D Deficient Patients With Stage 3 and 4 Chronic Kidney Disease (NCT NCT01029002)

NCT ID: NCT01029002

Last Updated: 2023-08-16

Results Overview

Urine albumin and creatinine were measured on spot urine specimens.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 74 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2023-08-16

Participant Flow

Participant milestones

Measure	Vitamin D 50000 IU Patients randomized to this arm will receive 50,000 IU of ergocalciferol in one unmarked pill once weekly. Vitamin D: Vitamin D, ergocalciferol, 50000 IU, weekly for 12 weeks, with open label extension for another 3 months	Placebo Patients randomized to this arm will receive a placebo pill once weekly. Placebo: Patients randomized to this arm will receive one placebo pill once weekly.
Overall Study STARTED	36	38
Overall Study COMPLETED	34	34
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Measure	Vitamin D 50000 IU Patients randomized to this arm will receive 50,000 IU of ergocalciferol in one unmarked pill once weekly. Vitamin D: Vitamin D, ergocalciferol, 50000 IU, weekly for 12 weeks, with open label extension for another 3 months	Placebo Patients randomized to this arm will receive a placebo pill once weekly. Placebo: Patients randomized to this arm will receive one placebo pill once weekly.
Overall Study Lost to Follow-up	2	4

Baseline Characteristics

The Effects of Vitamin D Repletion in Vitamin D Deficient Patients With Stage 3 and 4 Chronic Kidney Disease

Baseline characteristics by cohort

Measure	Vitamin D 50000 IU n=36 Participants Patients randomized to this arm will receive 50,000 IU of ergocalciferol in one unmarked pill once weekly. Vitamin D: Vitamin D, ergocalciferol, 50000 IU, weekly for 12 weeks, with open label extension for another 3 months	Placebo n=38 Participants Patients randomized to this arm will receive a placebo pill once weekly. Placebo: Patients randomized to this arm will receive one placebo pill once weekly.	Total n=74 Participants Total of all reporting groups
Age, Continuous	60.6 years STANDARD_DEVIATION 9.9 • n=5 Participants	55.3 years STANDARD_DEVIATION 14.3 • n=7 Participants	57.9 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	14 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	24 Participants n=7 Participants	42 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic White	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic Black	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	36 Participants n=5 Participants	38 Participants n=7 Participants	74 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Urine albumin and creatinine were measured on spot urine specimens.

Outcome measures

Measure	Vitamin D 50000 IU n=34 Participants Patients randomized to this arm will receive 50,000 IU of ergocalciferol in one unmarked pill once weekly. Vitamin D: Vitamin D, ergocalciferol, 50000 IU, weekly for 12 weeks, with open label extension for another 3 months	Placebo n=34 Participants Patients randomized to this arm will receive a placebo pill once weekly. Placebo: Patients randomized to this arm will receive one placebo pill once weekly.
Effect of Vitamin D Supplementation on Albuminuria in CKD Patients as Assessed by Urine Albumin/Creatinine Measures.	1126.68 mg/gram creatinine Standard Deviation 1505.26	1061.39 mg/gram creatinine Standard Deviation 1354.71

SECONDARY outcome

Timeframe: 3 months

25(OH) vitamin D levels were measured using liquid chromatography.

Outcome measures

Measure	Vitamin D 50000 IU n=36 Participants Patients randomized to this arm will receive 50,000 IU of ergocalciferol in one unmarked pill once weekly. Vitamin D: Vitamin D, ergocalciferol, 50000 IU, weekly for 12 weeks, with open label extension for another 3 months	Placebo n=38 Participants Patients randomized to this arm will receive a placebo pill once weekly. Placebo: Patients randomized to this arm will receive one placebo pill once weekly.
Effect of Repletion Doses of Vitamin D Increase 25(OH) Vitamin D Levels to Above 30 ng/mL in a Multi-ethnic Sample of Patients With CKD as a Secondary Outcome.	29.9 ng/mL Standard Deviation 13.8	17.1 ng/mL Standard Deviation 7.9

SECONDARY outcome

Timeframe: 3 months

Population: Ambulatory pressure data readings were not collected and therefore data was not able to be aggregated and analyzed.

Outcome measures

Outcome data not reported

Adverse Events

Vitamin D 50000 IU

Serious events: 12 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 17 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Vitamin D 50000 IU n=36 participants at risk Patients randomized to this arm will receive 50,000 IU of ergocalciferol in one unmarked pill once weekly. Vitamin D: Vitamin D, ergocalciferol, 50000 IU, weekly for 12 weeks, with open label extension for another 3 months	Placebo n=38 participants at risk Patients randomized to this arm will receive a placebo pill once weekly. Placebo: Patients randomized to this arm will receive one placebo pill once weekly.
Cardiac disorders Cardiac Hospitalization and ED Visits	8.3% 3/36 • Number of events 3 • 12 weeks	15.8% 6/38 • Number of events 6 • 12 weeks
General disorders Non-cardiac Hospitalization and ED Visits	25.0% 9/36 • 12 weeks	28.9% 11/38 • 12 weeks

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michal Melamed

Albert Einstein College of Medicine

Phone: 718-430-2304

Email: michal.melamed@einsteinmed.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place