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

Sponsor

Albany College of Pharmacy and Health Sciences (Other)

Overall Status

Terminated

CT.gov ID

NCT01312441

Collaborator

VA Office of Research and Development (U.S. Fed), Hortense & Louis Rubin Dialysis Center (Other), Satellite Healthcare (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Vitamin D Deficiency Renal Failure Chronic Requiring Hemodialysis	Drug: Ergocalciferol Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Drisdol
Placebo Comparator: Placebo Placebo by mouth once weekly for 6 months	Drug: Placebo Placebo by mouth once weekly for 6 months

Arm

Intervention/Treatment

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 Names:

Drisdol

Placebo Comparator: Placebo

Placebo by mouth once weekly for 6 months

Drug: Placebo

Placebo by mouth once weekly for 6 months

Outcome Measures

Primary Outcome Measures

The sustainability of 25-hydroxy-vitamin D levels after 6 months of vitamin D replenishment with ergocalciferol [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stratton VA Medical Center	Albany	New York	United States	12208
2	Hortense and Louis Rubin Dialysis Center	Clifton Park	New York	United States	12065
3	Hortense and Louis Rubin Dialysis Center	Saratoga Springs	New York	United States	12866
4	Hortense and Louis Rubin Dialysis Center	Troy	New York	United States	12180

Sponsors and Collaborators

Albany College of Pharmacy and Health Sciences
VA Office of Research and Development
Hortense & Louis Rubin Dialysis Center
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