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

Albany College of Pharmacy and Health Sciences

Status and phase: Terminated; Phase 4

Conditions: Renal Failure Chronic Requiring Hemodialysis; Vitamin D Deficiency

Treatments: Drug: Ergocalciferol; Drug: Placebo

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01312441

10-023 (Other Identifier)

00741

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

Ergocalciferol

Experimental group

Description:

Ergocalciferol 50,000 IU by mouth once weekly for 6 months

Treatment:

Drug: Ergocalciferol

Placebo

Placebo Comparator group

Description:

Placebo by mouth once weekly for 6 months

Treatment:

Drug: Placebo