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

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.

Study Overview

• Status: Completed
• Conditions: Proteinuria; Chronic Renal Insufficiency
• Intervention / Treatment: Drug: Vitamin D; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Placebo; Patients randomized to this arm will receive one placebo pill once weekly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.		3 months

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Michal Melamed, MD, MHS, Albert Einstein College of Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: December 7, 2009
• First Submitted That Met QC Criteria: December 8, 2009
• First Posted (Estimated): December 9, 2009

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Vitamin D; proteinuria; CKD
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urological Manifestations; Disease Attributes; Urination Disorders; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Proteinuria; Renal Insufficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: 2007-266; K23DK078774 (U.S. NIH Grant/Contract)