Clinical trial NCT01312441: Sustainability of Vitamin D Levels After Repletion With Ergocalciferol In Chronic Kidney Disease Stage 5D
Official title: Sustainability of 25-hydroxyvitamin D Levels, Inflammatory Reduction, and Endothelial Dysfunction After Repletion With Ergocalciferol in CKD Stage 5D
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Vitamin D Deficiency
Renal Failure Chronic Requiring Hemodialysis
Keywords: Vitamin D
Ergocalciferol
Lead sponsor: Albany College of Pharmacy and Health Sciences
Sponsor class: OTHER
Collaborators: name: VA Office of Research and Development
name: Hortense & Louis Rubin Dialysis Center
name: Satellite Healthcare
First posted: 2011-03-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The sustainability of 25-hydroxy-vitamin D levels after 6 months of vitamin D replenishment with ergocalciferol
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Albany
country: United States
facility: Stratton VA Medical Center
state: New York
city: Clifton Park
country: United States
facility: Hortense and Louis Rubin Dialysis Center
state: New York
city: Saratoga Springs
country: United States
facility: Hortense and Louis Rubin Dialysis Center
state: New York
city: Troy
country: United States
facility: Hortense and Louis Rubin Dialysis Center
state: New York
Study officials:
affiliation: Albany College of Pharmacy and Health Sciences
name: Darius L Mason, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Stratton Veteran Affairs Medical Center
name: Roy Mathew, MD
role: PRINCIPAL_INVESTIGATOR
References: