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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01114672
Recruitment Status : Completed
First Posted : May 3, 2010
Results First Posted : February 12, 2013
Last Update Posted : February 21, 2013
Sponsor:
Collaborator:
National Kidney Foundation
Information provided by (Responsible Party):
Mary Schanler, Winthrop University Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Pruritis Drug: 50,000 Units Ergocalciferol Drug: Placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : July 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Itching

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Severity of Pruritis [ Time Frame: 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01114672


Locations
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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
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Study Director: Steven Fishbane, MD Department of Nephrology, Winthrop Univ Hospital
Principal Investigator: Mary Schanler, MS, RD Winthrop University Hospital, Outpatient Dialysis
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mary Schanler, Administrative Dietitian, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT01114672    
Other Study ID Numbers: 10020
First Posted: May 3, 2010    Key Record Dates
Results First Posted: February 12, 2013
Last Update Posted: February 21, 2013
Last Verified: February 2013
Keywords provided by Mary Schanler, Winthrop University Hospital:
Pruritis in hemodialysis patients
25-Vitamin D in chronic kidney disease
Additional relevant MeSH terms:
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Pruritus
Skin Diseases
Skin Manifestations
Ergocalciferols
Vitamin D
 Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Bone Density Conservation Agents