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

Phase 4

Terminated

• Conditions: Renal Failure Chronic Requiring Hemodialysis; Vitamin D Deficiency
• Interventions: Drug: Placebo; Drug: Ergocalciferol

• Registration Number: NCT01312441
• Lead Sponsor: Albany College of Pharmacy and Health Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-03-09
• Study First Submitted QC: 2011-03-09
• Study First Posted: 2011-03-10
• Primary Completion: 2015-06
• Study Completion: 2015-08
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-13
• Last Update Posted: 2016-01-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo by mouth once weekly for 6 months
Ergocalciferol	Ergocalciferol	Ergocalciferol 50,000 IU by mouth once weekly for 6 months

Primary Outcome Measures

Name	Time	Method
The sustainability of 25-hydroxy-vitamin D levels after 6 months of vitamin D replenishment with ergocalciferol	12 months

Trial Locations

Locations (2)

Stratton VA Medical Center; 🇺🇸 Albany, New York, United States

Hortense and Louis Rubin Dialysis Center; 🇺🇸 Troy, New York, United States