A Study of Oral Ergocalciferol to Treat Pruritis in Hemodialysis Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Prospective, Double-Blind Placebo Controlled Study of Oral Ergocalciferol in the Treatment of Pruritis in Hemodialysis Patients

Conditions
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Pruritis

Intervention / Treatment
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* Drug: 50,000 Units Ergocalciferol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hemodialysis treatment for > 3 months Subjective complaint of excessive itching Exclusion Criteria: Age < 18 years Failure to provide informed consent Intact PTH < 70 pg/ml or > 1,000 pg/ml Serum phosphorus > 7.0 Serum calcium (adjusted for albumin)> 11 Active malignancy Likelihood of imminent renal transplantation Current ergocalciferol treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ergocalciferol<br> | Drug: 50,000 Units Ergocalciferol<br>* 50,000 Units oral ergocalciferol to be given once weekly<br>|
| Placebo Comparator: oral placebo<br> | Drug: Placebo<br>* oral placebo once weekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pruritis in hemodialysis patients, 25-Vitamin D in chronic kidney disease