Study Stopped
Low enrollment
Sustainability of Vitamin D Levels After Repletion With Ergocalciferol In Chronic Kidney Disease Stage 5D
Sustainability of 25-hydroxyvitamin D Levels, Inflammatory Reduction, and Endothelial Dysfunction After Repletion With Ergocalciferol in CKD Stage 5D
2 other identifiers
interventional
20
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2011
Longer than P75 for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 9, 2011
CompletedFirst Posted
Study publicly available on registry
March 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedJanuary 14, 2016
January 1, 2016
4.4 years
March 9, 2011
January 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The sustainability of 25-hydroxy-vitamin D levels after 6 months of vitamin D replenishment with ergocalciferol
12 months
Study Arms (2)
Ergocalciferol
EXPERIMENTALErgocalciferol 50,000 IU by mouth once weekly for 6 months
Placebo
PLACEBO COMPARATORPlacebo by mouth once weekly for 6 months
Interventions
Ergocalciferol capsules 50,000 IU once weekly for 6 months
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Activated vitamin D administration
- On chronic hemodialysis for ≥ 6 months
- Use of a synthetic biocompatible dialysis membrane
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Albany College of Pharmacy and Health Scienceslead
- VA Office of Research and Developmentcollaborator
- Hortense & Louis Rubin Dialysis Centercollaborator
- Satellite Healthcarecollaborator
Study Sites (4)
Stratton VA Medical Center
Albany, New York, 12208, United States
Hortense and Louis Rubin Dialysis Center
Clifton Park, New York, 12065, United States
Hortense and Louis Rubin Dialysis Center
Saratoga Springs, New York, 12866, United States
Hortense and Louis Rubin Dialysis Center
Troy, New York, 12180, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Darius L Mason, Pharm.D.
Albany College of Pharmacy and Health Sciences
- PRINCIPAL INVESTIGATOR
Roy Mathew, MD
Stratton Veteran Affairs Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
March 9, 2011
First Posted
March 10, 2011
Study Start
January 1, 2011
Primary Completion
June 1, 2015
Study Completion
August 1, 2015
Last Updated
January 14, 2016
Record last verified: 2016-01