NCT01114672

A Study of Oral Ergocalciferol to Treat Pruritis in Hemodialysis Patients

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Winthrop University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pruritis

Interventions

Type	Name	Description
DRUG	50,000 Units Ergocalciferol	50,000 Units oral ergocalciferol to be given once weekly
DRUG	Placebo	oral placebo once weekly

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-11-01
• Completion: 2012-02-01
• First posted: 2010-05-03
• Last updated: 2013-02-21
• Results posted: 2013-02-12

Locations

2 sites across 1 country: United States