Trial | NCT01312441  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    20
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 Started
Jan 31
2011
Primary Completion
Jun 30
2015
Study Completion
Aug 31
2015
Last Update
Jan 14
2016
Estimate

Drug Ergocalciferol

Ergocalciferol capsules 50,000 IU once weekly for 6 months

  • Other names: Drisdol

Drug Placebo

Placebo by mouth once weekly for 6 months

Ergocalciferol Experimental

Ergocalciferol 50,000 IU by mouth once weekly for 6 months

Placebo Placebo Comparator

Placebo by mouth once weekly for 6 months

Criteria 

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
No Results Posted