A Study of Oral Ergocalciferol to Treat Pruritis in Hemodialysis Patients (CRN11)
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ClinicalTrials.gov Identifier: NCT01114672 |
Recruitment Status :
Completed
First Posted : May 3, 2010
Results First Posted : February 12, 2013
Last Update Posted : February 21, 2013
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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 |
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 |

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 |
- 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.

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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 |
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

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
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 |
Study Director: | Steven Fishbane, MD | Department of Nephrology, Winthrop Univ Hospital | |
Principal Investigator: | Mary Schanler, MS, RD | Winthrop University Hospital, Outpatient Dialysis |
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 |
Pruritis in hemodialysis patients 25-Vitamin D in chronic kidney disease |
Pruritus Skin Diseases Skin Manifestations Ergocalciferols Vitamin D |
Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vitamins Micronutrients Bone Density Conservation Agents |