Sustainability of Vitamin D Levels After Repletion With Ergocalciferol In Chronic Kidney Disease Stage 5D
This study is currently recruiting participants.
Verified December 2011 by Albany College of Pharmacy and Health Sciences
Sponsor:
Albany College of Pharmacy and Health Sciences
Collaborators:
Hortense and Louis Rubin Dialysis Centers
Satellite Healthcare
Information provided by (Responsible Party):
Darius Mason, Albany College of Pharmacy and Health Sciences
ClinicalTrials.gov Identifier:
NCT01312441
First received: March 9, 2011
Last updated: December 29, 2011
Last verified: December 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Vitamin D Deficiency Renal Failure Chronic Requiring Hemodialysis |
Drug: Ergocalciferol Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Sustainability of 25-hydroxyvitamin D Levels, Inflammatory Reduction, and Endothelial Dysfunction After Repletion With Ergocalciferol in CKD Stage 5D |
Resource links provided by NLM:
Further study details as provided by Albany College of Pharmacy and Health Sciences:
Primary Outcome Measures:
- The sustainability of 25-hydroxy-vitamin D levels after 6 months of vitamin D replenishment with ergocalciferol [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 56 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ergocalciferol
Ergocalciferol 50,000 IU by mouth once weekly for 6 months
|
Drug: Ergocalciferol
Ergocalciferol capsules 50,000 IU once weekly for 6 months
Other Name: Drisdol
|
|
Placebo Comparator: Placebo
Placebo by mouth once weekly for 6 months
|
Drug: Placebo
Placebo by mouth once weekly for 6 months
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01312441
Contacts
| Contact: Darius L Mason, Pharm.D. | (518) 694-7188 | darius.mason@acphs.edu |
| Contact: Magdalene M Assimon, Pharm.D. | (518) 694-7289 | magdalene.assimon@acphs.edu |
Locations
| United States, New York | |
| Stratton VA Medical Center | Recruiting |
| Albany, New York, United States, 12208 | |
| Hortense and Louis Rubin Dialysis Center | Recruiting |
| Clifton Park, New York, United States, 12065 | |
| Hortense and Louis Rubin Dialysis Center | Recruiting |
| Saratoga Springs, New York, United States, 12866 | |
| Hortense and Louis Rubin Dialysis Center | Recruiting |
| Troy, New York, United States, 12180 | |
Sponsors and Collaborators
Albany College of Pharmacy and Health Sciences
Hortense and Louis Rubin Dialysis Centers
Satellite Healthcare
Investigators
| Principal Investigator: | Darius L Mason, Pharm.D. | Albany College of Pharmacy and Health Sciences |
| Principal Investigator: | Roy Mathew, MD | Stratton Veteran Affairs Medical Center |
More Information
No publications provided
| Responsible Party: | Darius Mason, PI, Albany College of Pharmacy and Health Sciences |
| ClinicalTrials.gov Identifier: | NCT01312441 History of Changes |
| Other Study ID Numbers: | 00741, 10-023 |
| Study First Received: | March 9, 2011 |
| Last Updated: | December 29, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Albany College of Pharmacy and Health Sciences:
|
Vitamin D Ergocalciferol |
Additional relevant MeSH terms:
|
Kidney Failure, Chronic Renal Insufficiency Vitamin D Deficiency Renal Insufficiency, Chronic Kidney Diseases Urologic Diseases Avitaminosis Deficiency Diseases Malnutrition |
Nutrition Disorders Ergocalciferols Vitamin D Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on June 18, 2013