A Study of Oral Ergocalciferol to Treat Pruritis in Hemodialysis Patients

Phase 4

Completed

• Conditions: Pruritis
• Interventions: Drug: 50,000 Units Ergocalciferol; Drug: Placebo

• Registration Number: NCT01114672
• Lead Sponsor: Winthrop University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2010-04-29
• Study First Submitted QC: 2010-04-30
• Study First Posted: 2010-05-03
• Study Start: 2010-07
• Primary Completion: 2011-11
• Study Completion: 2012-02
• Results First Submitted: 2013-01-08
• Results First Submitted QC: 2013-01-08
• Status Verified: 2013-02
• Results First Posted: 2013-02-12
• Last Update Submitted: 2013-02-15
• Last Update Posted: 2013-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ergocalciferol	50,000 Units Ergocalciferol	-
oral placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Severity of Pruritis	Baseline and end of study (up to 12 weeks)	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.

Trial Locations

Locations (2)

Winthrop Univ Hospital Outpatient Dialysis; 🇺🇸 Mineola, New York, United States

Winthop Univ Hospital Outpatient Dialysis at Bethpage; 🇺🇸 Bethpage, New York, United States