Pruritis Clinical Trial
— CRN11Official title:
A Randomized Prospective, Double-Blind Placebo Controlled Study of Oral Ergocalciferol in the Treatment of Pruritis in Hemodialysis Patients
Verified date | February 2013 |
Source | Winthrop University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | February 2012 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: 1. Hemodialysis treatment for > 3 months 2. Subjective complaint of excessive itching Exclusion Criteria: 1. Age < 18 years 2. Failure to provide informed consent 3. Intact PTH < 70 pg/ml or > 1,000 pg/ml 4. Serum phosphorus > 7.0 5. Serum calcium (adjusted for albumin)> 11 6. Active malignancy 7. Likelihood of imminent renal transplantation 8. Current ergocalciferol treatment |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Winthop Univ Hospital Outpatient Dialysis at Bethpage | Bethpage | New York |
United States | Winthrop Univ Hospital Outpatient Dialysis | Mineola | New York |
Lead Sponsor | Collaborator |
---|---|
Winthrop University Hospital | National Kidney Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Severity of Pruritis | 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. |
Baseline and end of study (up to 12 weeks) | No |
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