Conditions: Chronic Renal Insufficiency Proteinuria
Keywords: Vitamin D CKD proteinuria
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 74
Healthy volunteers: no

Brief summary:
A randomized clinical trial to determine if vitamin D repletion in CKD (Chronic Kidney Disease) patients with low vitamin D levels will decrease proteinuria, a marker of kidney damage.

Detailed description:
This RCT will enroll 74 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.

Arms:
arm 1: Patients randomized to this arm will receive 50,000 IU of ergocalciferol in one unmarked pill once weekly. arm 2: Patients randomized to this arm will receive a placebo pill once weekly.

Interventions: intervention 1: Vitamin D intervention 2: Placebo
Intervention descriptions: intervention 1: Vitamin D, ergocalciferol, 50000 IU, weekly for 12 weeks, with open label extension for another 3 months intervention 2: Patients randomized to this arm will receive one placebo pill once weekly.

Protocol document: