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

Albert Einstein College of Medicine74 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Renal Insufficiency Proteinuria

Interventions

Vitamin DDRUG

Vitamin D, ergocalciferol, 50000 IU, weekly for 12 weeks, with open label extension for another 3 months

PlaceboOTHER

Patients randomized to this arm will receive one placebo pill once weekly.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age \>18 years * Ability to provide informed consent * Chronic kidney disease stage 3 and 4 * On ACE inhibitor or ARB for albuminuria if tolerated * Assessed during eligibility screen: * Albuminuria \>30 mg/g creatinine * 25(OH) vitamin D level \>12.5 and \<75 nmol/L Exclusion Criteria: * On vitamin D in past 4 weeks * Plans to relocate out of New York City in the next 6 months * 25 (OH) Vitamin D level \<12.5 nmol/L * HIV infection * History of hypercalcemia or kidney stones * Serum phosphate \>5.5 mg/dl in past 3 months * Serum calcium \>10.0 mg/dl in past 3 months * SBP \>160 DBP \>100 at screening visit * Transplanted organ * Cancer * Polycystic kidney disease * Rapidly deteriorating kidney function with the expectation for initiation of dialysis in less than 6 months

Locations (1)

Montefiore medical center

The Bronx, New York, United States

Outcomes

Primary Outcomes

Effect of Vitamin D Supplementation on Albuminuria in CKD Patients as Assessed by Urine Albumin/Creatinine Measures.

Urine albumin and creatinine were measured on spot urine specimens.

Time frame: 3 months

Secondary Outcomes

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.

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

Time frame: 3 months

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.