The Effects of Vitamin D Repletion in Vitamin D Deficient Patients With Stage 3 and 4 Chronic Kidney Disease
|Chronic Renal Insufficiency Proteinuria||Drug: Vitamin D Other: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effects of Vitamin D Repletion in Vitamin D Deficient Patients With Stage 3 and 4 Chronic Kidney Disease|
- To assess the effect of vitamin D supplementation on albuminuria in CKD patients as assessed by urine albumin/creatinine measures. [ Time Frame: 3 months ]
- To assess whether 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. [ Time Frame: 3 months ]
- To assess the effect of vitamin D supplementation on mean systolic blood pressure as measured by ambulatory blood pressure in CKD patients as a secondary outcome. [ Time Frame: 3 months ]
|Study Start Date:||October 2009|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: Vitamin D 50000 IU
Patients randomized to this arm will receive 50,000 IU of ergocalciferol in one unmarked pill once weekly.
Drug: Vitamin D
Vitamin D, ergocalciferol, 50000 IU, weekly for 12 weeks, with open label extension for another 3 months
Placebo Comparator: Placebo
Patients randomized to this arm will receive a placebo pill once weekly.
Patients randomized to this arm will receive one placebo pill once weekly.
This RCT will enroll 75 subjects, men and women over age of 18, with stage 3-4 CKD from various causes including diabetes and hypertension. Patients will be recruited from the Montefiore Medical Center Nephrology clinics and the Montefiore Medical Center internal medicine clinics and other interested individuals.
Informed consent will be obtained on all subjects. All subjects with meet with one of the investigators who will verbally explain to them the purpose of the study and the alternatives.
Blood and urine tests will be collected to assess for proteinuria, vitamin D levels, serum creatinine, calcium and phosphorus, as well as a urine albumin, calcium and creatinine. These tests will be used for experimental purposes only and will be collected at each study visit over the span of 6 months.
There will be two arms, an arm randomized to 50000IU of ergocalciferol once weekly and a placebo arm for 3 months. For an additional 3 months, all patients will be repleted with Vitamin D via open-label extension, based on their levels after 3 months.
Secondary outcomes include ambulatory blood pressure monitoring, hemoglobin A1c, HOMA-IR.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01029002
|United States, New York|
|Montefiore medical center|
|Bronx, New York, United States, 10467|
|Principal Investigator:||Michal Melamed, MD, MHS||Albert Einstein College of Medicine, Inc.|