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Sustainability of Vitamin D Levels After Repletion With Ergocalciferol In Chronic Kidney Disease Stage 5D

NCT01312441 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-01-14

No results posted yet for this study

Summary

The prevalence of vitamin D deficiency increases as kidney function declines. As a result, many hemodialysis patients often have low levels of vitamin D. Recent evidence has shown that vitamin D supplementation may improve many aspects of poor health such as heart disease and inflammatory markers. The objectives of this study are to determine how supplementing dialysis patients with ergocalciferol increases vitamin D levels, how long vitamin D levels can be maintained after a 6 month treatment course, and to examine the effect of ergocalciferol on biomarkers of inflammation and vascular health.

Conditions

  • Vitamin D Deficiency
  • Renal Failure Chronic Requiring Hemodialysis

Interventions

DRUG

Ergocalciferol

Ergocalciferol capsules 50,000 IU once weekly for 6 months

DRUG

Placebo

Placebo by mouth once weekly for 6 months

Sponsors & Collaborators

  • VA Office of Research and Development

    collaborator FED

  • Hortense & Louis Rubin Dialysis Center

    collaborator OTHER

  • Satellite Healthcare

    collaborator OTHER

  • Albany College of Pharmacy and Health Sciences

    lead OTHER

Principal Investigators

  • Darius L Mason, Pharm.D. · Albany College of Pharmacy and Health Sciences

  • Roy Mathew, MD · Stratton Veteran Affairs Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2015-06-30
Completion
2015-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01312441 on ClinicalTrials.gov