Phase 4 N=50 Randomized Double-blind Treatment

A Study of Oral Ergocalciferol to Treat Pruritis in Hemodialysis Patients

Pruritis

Bottom Line

View on ClinicalTrials.gov: NCT01114672 ↗

Enrolled (actual)

Serious AEs

6.0%

Results posted

Feb 2013

Primary outcome: Primary: Severity of Pruritis — 10.88; 9.76; 6.64; 5.12 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: 50,000 Units Ergocalciferol (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Winthrop University Hospital
Primary completion: Nov 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Severity of Pruritis	10.88; 9.76; 6.64; 5.12	—

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.

Eligibility Criteria

Inclusion Criteria

Hemodialysis treatment for > 3 months
Subjective complaint of excessive itching

Exclusion Criteria

Age 1,000 pg/ml
Serum phosphorus > 7.0
Serum calcium (adjusted for albumin)> 11
Active malignancy
Likelihood of imminent renal transplantation
Current ergocalciferol treatment

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01114672). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.