Sustainability of 25-hydroxyvitamin D Levels, Inflammatory Reduction, and Endothelial Dysfunction After Repletion With Ergocalciferol in CKD Stage 5D
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Albany |
| State: |
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New York |
| Zip Code: |
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12208 |
| Conditions: |
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Vitamin D Deficiency - Renal Failure Chronic Requiring Hemodialysis |
| Purpose: |
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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.
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| Study Summary: |
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| 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
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| NCT ID: |
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NCT01312441 |
| Primary Contact: |
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Principal Investigator
Darius L Mason, Pharm.D.
Albany College of Pharmacy and Health Sciences
Darius L Mason, Pharm.D.
Phone: (518) 694-7188
Email: darius.mason@acphs.edu
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| Backup Contact: |
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Email: magdalene.assimon@acphs.edu
Magdalene M Assimon, Pharm.D.
Phone: (518) 694-7289
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| Location Contact: |
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Albany, New York 12208
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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