A Study of Oral Ergocalciferol to Treat Pruritis in Hemodialysis Patients (CRN11)
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| Tracking Information | |||||||||
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| First Received Date ICMJE | April 29, 2010 | ||||||||
| Last Updated Date | February 15, 2013 | ||||||||
| Start Date ICMJE | July 2010 | ||||||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE |
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. |
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| Change History | Complete list of historical versions of study NCT01114672 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A Study of Oral Ergocalciferol to Treat Pruritis in Hemodialysis Patients | ||||||||
| Official Title ICMJE | A Randomized Prospective, Double-Blind Placebo Controlled Study of Oral Ergocalciferol in the Treatment of Pruritis in Hemodialysis Patients | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Pruritis | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 50 | ||||||||
| Completion Date | February 2012 | ||||||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 85 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01114672 | ||||||||
| Other Study ID Numbers ICMJE | 10020 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Mary Schanler, Winthrop University Hospital | ||||||||
| Study Sponsor ICMJE | Winthrop University Hospital | ||||||||
| Collaborators ICMJE | National Kidney Foundation | ||||||||
| Investigators ICMJE |
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| Information Provided By | Winthrop University Hospital | ||||||||
| Verification Date | February 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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