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

This study is currently recruiting participants.
Verified November 2013 by Albany College of Pharmacy and Health Sciences
Sponsor:
Collaborators:
Hortense and Louis Rubin Dialysis Centers
Satellite Healthcare
Information provided by (Responsible Party):
Darius Mason, Albany College of Pharmacy and Health Sciences
ClinicalTrials.gov Identifier:
NCT01312441
First received: March 9, 2011
Last updated: November 22, 2013
Last verified: November 2013

March 9, 2011
November 22, 2013
January 2011
June 2015   (final data collection date for primary outcome measure)
The sustainability of 25-hydroxy-vitamin D levels after 6 months of vitamin D replenishment with ergocalciferol [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01312441 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Sustainability of Vitamin D Levels After Repletion With Ergocalciferol In Chronic Kidney Disease Stage 5D
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Vitamin D Deficiency
  • Renal Failure Chronic Requiring Hemodialysis
  • Drug: Ergocalciferol
    Ergocalciferol capsules 50,000 IU once weekly for 6 months
    Other Name: Drisdol
  • Drug: Placebo
    Placebo by mouth once weekly for 6 months
  • Experimental: Ergocalciferol
    Ergocalciferol 50,000 IU by mouth once weekly for 6 months
    Intervention: Drug: Ergocalciferol
  • Placebo Comparator: Placebo
    Placebo by mouth once weekly for 6 months
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
56
August 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Darius L Mason, Pharm.D. (518) 694-7188 darius.mason@acphs.edu
Contact: Magdalene M Assimon, Pharm.D. (518) 694-7289 magdalene.assimon@acphs.edu
United States
 
NCT01312441
00741, 10-023
No
Darius Mason, Albany College of Pharmacy and Health Sciences
Albany College of Pharmacy and Health Sciences
  • Department of Veterans Affairs
  • Hortense and Louis Rubin Dialysis Centers
  • Satellite Healthcare
Principal Investigator: Darius L Mason, Pharm.D. Albany College of Pharmacy and Health Sciences
Principal Investigator: Roy Mathew, MD Stratton Veteran Affairs Medical Center
Albany College of Pharmacy and Health Sciences
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP