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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Pruritis
 Drug: 50,000 Units Ergocalciferol
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Prospective, Double-Blind Placebo Controlled Study of Oral Ergocalciferol in the Treatment of Pruritis in Hemodialysis Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Winthrop University Hospital:

Primary Outcome Measures:
  • 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.
Enrollment: 50
Study Start Date: July 2010
Study Completion Date: February 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ergocalciferol Drug: 50,000 Units Ergocalciferol
50,000 Units oral ergocalciferol to be given once weekly
Placebo Comparator: oral placebo Drug: Placebo
oral placebo once weekly

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.

  Eligibility
Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01114672

Locations
United States, New York
Winthop Univ Hospital Outpatient Dialysis at Bethpage
Bethpage, New York, United States, 11714
Winthrop Univ Hospital Outpatient Dialysis
Mineola, New York, United States, 11501
Sponsors and Collaborators
Winthrop University Hospital
National Kidney Foundation
Investigators
Study Director: Steven Fishbane, MD Department of Nephrology, Winthrop Univ Hospital
Principal Investigator: Mary Schanler, MS, RD Winthrop University Hospital, Outpatient Dialysis
  More Information

No publications provided by Winthrop University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mary Schanler, Administrative Dietitian, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT01114672     History of Changes
Other Study ID Numbers: 10020
Study First Received: April 29, 2010
Results First Received: January 8, 2013
Last Updated: February 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Winthrop University Hospital:
Pruritis in hemodialysis patients
25-Vitamin D in chronic kidney disease

Additional relevant MeSH terms:
Pruritus
Signs and Symptoms
Skin Diseases
Skin Manifestations
Ergocalciferols
Vitamin D
 Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamins

ClinicalTrials.gov processed this record on February 27, 2015