A Study of Oral Ergocalciferol to Treat Pruritis in Hemodialysis Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-02-29

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.

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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.

Conditions

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Pruritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ergocalciferol

Group Type ACTIVE_COMPARATOR

50,000 Units Ergocalciferol

Intervention Type DRUG

50,000 Units oral ergocalciferol to be given once weekly

oral placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral placebo once weekly

Interventions

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50,000 Units Ergocalciferol

50,000 Units oral ergocalciferol to be given once weekly

Intervention Type DRUG

Placebo

oral placebo once weekly

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No