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A Study of Oral Ergocalciferol to Treat Pruritis in Hemodialysis Patients (CRN11)

This study has been completed.
Sponsor:
Collaborator:
National Kidney Foundation
Information provided by (Responsible Party):
Mary Schanler, Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT01114672
First received: April 29, 2010
Last updated: February 15, 2013
Last verified: February 2013

April 29, 2010
February 15, 2013
July 2010
November 2011   (final data collection date for primary outcome measure)
Severity of Pruritis [ Time Frame: Baseline and end of study (up to 12 weeks) ] [ Designated as safety issue: No ]

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.

Change in severity of Pruritis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Randomized patients will fill out a survey with questions about the degree and location of their pruritis at baseline and then every 2 weeks until the end of study. Vitamin D and metabolite levels will be measured at baseline, mid study,and on completion of study.
Complete list of historical versions of study NCT01114672 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pruritis
  • Drug: 50,000 Units Ergocalciferol
    50,000 Units oral ergocalciferol to be given once weekly
  • Drug: Placebo
    oral placebo once weekly
  • Active Comparator: Ergocalciferol
    Intervention: Drug: 50,000 Units Ergocalciferol
  • Placebo Comparator: oral placebo
    Intervention: Drug: Placebo
Shirazian S, Schanler M, Shastry S, Dwivedi S, Kumar M, Rice K, Miyawaki N, Ghosh S, Fishbane S. The effect of ergocalciferol on uremic pruritus severity: a randomized controlled trial. J Ren Nutr. 2013 Jul;23(4):308-14. doi: 10.1053/j.jrn.2012.12.007. Epub 2013 Feb 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
February 2012
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01114672
10020
No
Mary Schanler, Winthrop University Hospital
Winthrop University Hospital
National Kidney Foundation
Study Director: Steven Fishbane, MD Department of Nephrology, Winthrop Univ Hospital
Principal Investigator: Mary Schanler, MS, RD Winthrop University Hospital, Outpatient Dialysis
Winthrop University Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP