Sustainability of Vitamin D Levels After Repletion With Ergocalciferol In Chronic Kidney Disease Stage 5D
Information source: Albany College of Pharmacy and Health Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vitamin D Deficiency; Renal Failure Chronic Requiring Hemodialysis
Intervention: Ergocalciferol (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Albany College of Pharmacy and Health Sciences Official(s) and/or principal investigator(s):
Darius L Mason, Pharm.D., Principal Investigator, Affiliation: Albany College of Pharmacy and Health Sciences
Roy Mathew, MD, Principal Investigator, Affiliation: Stratton Veteran Affairs Medical Center
Overall contact:
Darius L Mason, Pharm.D., Phone: (518) 694-7188, Email: darius.mason@acphs.edu
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.
Clinical Details
Official title: Sustainability of 25-hydroxyvitamin D Levels, Inflammatory Reduction, and Endothelial Dysfunction After Repletion With Ergocalciferol in CKD Stage 5D
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: The sustainability of 25-hydroxy-vitamin D levels after 6 months of vitamin D replenishment with ergocalciferol
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Darius L Mason, Pharm.D., Phone: (518) 694-7188, Email: darius.mason@acphs.edu
Stratton VA Medical Center, Albany, New York 12208, United States; Recruiting
Hortense and Louis Rubin Dialysis Center, Clifton Park, New York 12065, United States; Recruiting
Hortense and Louis Rubin Dialysis Center, Saratoga Springs, New York 12866, United States; Recruiting
Hortense and Louis Rubin Dialysis Center, Troy, New York 12180, United States; Recruiting
Additional Information
Starting date: January 2011
Last updated: January 15, 2015
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