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

January 13, 2016 updated by: Darius Mason, Albany College of Pharmacy and Health Sciences

Sustainability of 25-hydroxyvitamin D Levels, Inflammatory Reduction, and Endothelial Dysfunction After Repletion With Ergocalciferol in CKD Stage 5D

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Albany, New York, United States, 12208
        • Stratton VA Medical Center
      • Clifton Park, New York, United States, 12065
        • Hortense and Louis Rubin Dialysis Center
      • Saratoga Springs, New York, United States, 12866
        • Hortense and Louis Rubin Dialysis Center
      • Troy, New York, United States, 12180
        • Hortense and Louis Rubin Dialysis Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Activated vitamin D administration
  • On chronic hemodialysis for ≥ 6 months
  • Use of a synthetic biocompatible dialysis membrane
  • 25-hydroxyvitamin D levels < 30 ng/mL
  • Corrected serum calcium < 10.2 mg/dL
  • Serum phosphate < 7 mg/dL
  • Iron replete (Ferritin > 200 ng/mL and transferrin saturation > 20%)

Exclusion Criteria:

  • Current participation in any other investigational drug trial
  • Vitamin D deficiency due to a heredity disorder
  • Liver disease or failure
  • Current or past treatment with ergocalciferol or cholecalciferol ≥ 2000 IU per day (within the past 6 months)
  • Treatment with calcimimetics or bisphosphonates within the last 3 months
  • Treatment with anti-epileptics or other medications that can effect vitamin D metabolism
  • Malnutrition (serum albumin < 2.5 mg/dL)
  • Pregnancy, positive pregnancy test or breastfeeding
  • Malignancy or other significant inflammatory disease
  • HIV/AIDS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ergocalciferol
Ergocalciferol 50,000 IU by mouth once weekly for 6 months
Drug: Ergocalciferol
Ergocalciferol capsules 50,000 IU once weekly for 6 months
Other Names:
  • Drisdol
Placebo Comparator: Placebo
Placebo by mouth once weekly for 6 months
Drug: Placebo
Placebo by mouth once weekly for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The sustainability of 25-hydroxy-vitamin D levels after 6 months of vitamin D replenishment with ergocalciferol
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albany College of Pharmacy and Health Sciences

Collaborators

VA Office of Research and Development
Satellite Healthcare
Hortense & Louis Rubin Dialysis Center

Investigators

  • Principal Investigator: Darius L Mason, Pharm.D., Albany College of Pharmacy and Health Sciences
  • Principal Investigator: Roy Mathew, MD, Stratton Veteran Affairs Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

March 9, 2011

First Submitted That Met QC Criteria

March 9, 2011

First Posted (Estimate)

March 10, 2011

Study Record Updates

Last Update Posted (Estimate)

January 14, 2016

Last Update Submitted That Met QC Criteria

January 13, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00741
  • 10-023 (Other Identifier: Albany College of Pharmacy and Health Sciences)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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