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

Overview

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.

Full Title of Study: “Sustainability of 25-hydroxyvitamin D Levels, Inflammatory Reduction, and Endothelial Dysfunction After Repletion With Ergocalciferol in CKD Stage 5D”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: June 2015

Interventions

  • Drug: Ergocalciferol
    • Ergocalciferol capsules 50,000 IU once weekly for 6 months
  • Drug: Placebo
    • Placebo by mouth once weekly for 6 months

Arms, Groups and Cohorts

  • Experimental: Ergocalciferol
    • Ergocalciferol 50,000 IU by mouth once weekly for 6 months
  • Placebo Comparator: Placebo
    • Placebo by mouth once weekly for 6 months

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Albany College of Pharmacy and Health Sciences
  • Collaborator
    • VA Office of Research and Development
  • Provider of Information About this Clinical Study
    • Principal Investigator: Darius Mason, PI – Albany College of Pharmacy and Health Sciences
  • Overall Official(s)
    • Darius L Mason, Pharm.D., Principal Investigator, Albany College of Pharmacy and Health Sciences
    • Roy Mathew, MD, Principal Investigator, Stratton Veteran Affairs Medical Center

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