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

• Status: Terminated
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albany College of Pharmacy and Health Sciences
• Collaborators: Hortense & Louis Rubin Dialysis Center; Satellite Healthcare; VA Office of Research and Development
• Treatments: Ergocalciferols; Vitamin D

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