A Study of Oral Ergocalciferol to Treat Pruritis in Hemodialysis Patients (CRN11)
Pruritis (itching) is common in many people with chronic renal failure on hemodialysis. There may be many different reasons for the pruritis. Efforts to treat the problem have not been very effective.
Vitamin D levels have been found to be low in many hemodialysis patients. Since vitamin D plays an important role in the skin and is effective in treatment of certain skin conditions that involve pruritis, it may have a role in treatment of pruritis in hemodialysis patients.
The objective of the investigators study is to determine the effect of supplementation with oral vitamin D2 (ergocalciferol) on pruritis in hemodialysis patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized Prospective, Double-Blind Placebo Controlled Study of Oral Ergocalciferol in the Treatment of Pruritis in Hemodialysis Patients|
- Severity of Pruritis [ Time Frame: Baseline and end of study (up to 12 weeks) ] [ Designated as safety issue: No ]
Randomized patients will fill out a survey with questions about the degree and location of their pruritis at baseline and end of study. The total score ranged from 0-21 with 21 being the most severe and zero being the absence of any of the measures of pruritis.
Last observation was carried forward to end of study. A decrease in the Severity of Pruritis score over time indicated an improvement in the severity of pruritis.
|Study Start Date:||July 2010|
|Study Completion Date:||February 2012|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: Ergocalciferol||
Drug: 50,000 Units Ergocalciferol
50,000 Units oral ergocalciferol to be given once weekly
|Placebo Comparator: oral placebo||
oral placebo once weekly
Vitamin D2 is a fat soluble steroid hormone precursor which must be hydroxylated in the liver and kidney respectively to make the active form 1-25-Vitamin D. This active metabolite and related analogs have been synthesized and are frequently used in the treatment of hyperparathyroidism in patients with chronic kidney disease. However the active metabolite may not be back metabolized to the precursor forms which may have functions in other organs including the skin. Supplementation of hemodialysis patients with oral vitamin D forms would provide a source of precursors for use throughout the body.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01114672
|United States, New York|
|Winthop Univ Hospital Outpatient Dialysis at Bethpage|
|Bethpage, New York, United States, 11714|
|Winthrop Univ Hospital Outpatient Dialysis|
|Mineola, New York, United States, 11501|
|Study Director:||Steven Fishbane, MD||Department of Nephrology, Winthrop Univ Hospital|
|Principal Investigator:||Mary Schanler, MS, RD||Winthrop University Hospital, Outpatient Dialysis|