A Study of Oral Ergocalciferol to Treat Pruritis in Hemodialysis Patients (CRN11)
This study has been completed.
Sponsor:
Winthrop University Hospital
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
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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:
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 (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Hemodialysis treatment for > 3 months
- Subjective complaint of excessive itching
Exclusion Criteria:
- Age < 18 years
- Failure to provide informed consent
- Intact PTH < 70 pg/ml or > 1,000 pg/ml
- Serum phosphorus > 7.0
- Serum calcium (adjusted for albumin)> 11
- Active malignancy
- Likelihood of imminent renal transplantation
- Current ergocalciferol treatment
Contacts and Locations
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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
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
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 Skin Diseases Skin Manifestations Signs and Symptoms Ergocalciferols Vitamin D |
Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on September 26, 2016