A Study of Oral Ergocalciferol to Treat Pruritis in Hemodialysis Patients

Pruritis Clinical Trial

— CRN11  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01114672
• Other study ID #: 10020
• Status: Completed
• Phase: Phase 4
• First received: April 29, 2010
• Last updated: February 15, 2013
• Start date: July 2010
• Est. completion date: February 2012

Study information

• 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

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pruritis
• Pruritus

Intervention

Drug:
• 50,000 Units Ergocalciferol
50,000 Units oral ergocalciferol to be given once weekly
• Placebo
oral placebo once weekly

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Winthrop University Hospital	National Kidney Foundation

Country where clinical trial is conducted

United States, 

Outcome

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