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

Study Overview
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Brief Summary
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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.

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

Conditions
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Vitamin D Deficiency, Renal Failure Chronic Requiring Hemodialysis

Intervention / Treatment
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* Drug: Ergocalciferol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ergocalciferol<br>Ergocalciferol 50,000 IU by mouth once weekly for 6 months | Drug: Ergocalciferol<br>* Ergocalciferol capsules 50,000 IU once weekly for 6 months<br>* Other names: Drisdol;|
| Placebo Comparator: Placebo<br>Placebo by mouth once weekly for 6 months | Drug: Placebo<br>* Placebo by mouth once weekly for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Ergocalciferol