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

NCT01029002 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2023-08-16

Study results available
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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.

Conditions

  • Chronic Renal Insufficiency
  • Proteinuria

Interventions

DRUG

Vitamin D

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

OTHER

Placebo

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

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH
  • Albert Einstein College of Medicine

    lead OTHER

Principal Investigators

  • Michal Melamed, MD, MHS · Albert Einstein College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01029002 on ClinicalTrials.gov