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

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Vitamin D Deficiency, Renal Failure Chronic Requiring Hemodialysis

In brief

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.

Key facts

Study ID

NCT01312441

Run by

Albany College of Pharmacy and Health Sciences

People needed

20

Starts

2011-01-01

Expected to finish

2015-08-01

Last updated by the study team

2016-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%)

You may not qualify if…

• 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

Where it is running

• Stratton VA Medical Center — Albany, New York, United States
• Hortense and Louis Rubin Dialysis Center — Clifton Park, New York, United States
• Hortense and Louis Rubin Dialysis Center — Saratoga Springs, New York, United States
• Hortense and Louis Rubin Dialysis Center — Troy, New York, United States

Full record on ClinicalTrials.gov

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