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

Vitamin D Deficiency Clinical Trial

Official title:

Sustainability of 25-hydroxyvitamin D Levels, Inflammatory Reduction, and Endothelial Dysfunction After Repletion With Ergocalciferol in CKD Stage 5D

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01312441
• Other study ID #: 00741
• Secondary ID: 10-023
• Status: Terminated
• Phase: Phase 4
• First received: March 9, 2011
• Last updated: January 13, 2016
• Start date: January 2011
• Est. completion date: August 2015

Study information

• Verified date: January 2016
• Source: Albany College of Pharmacy and Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Failure Chronic Requiring Hemodialysis
• Vitamin D Deficiency

Intervention

Drug:
• Ergocalciferol
Ergocalciferol capsules 50,000 IU once weekly for 6 months
• Placebo
Placebo by mouth once weekly for 6 months

Locations

Country	Name	City	State
United States	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

Sponsors (4)

Lead Sponsor	Collaborator
Albany College of Pharmacy and Health Sciences	Hortense & Louis Rubin Dialysis Center, Satellite Healthcare, VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sustainability of 25-hydroxy-vitamin D levels after 6 months of vitamin D replenishment with ergocalciferol		12 months	No