A Study of Oral Ergocalciferol to Treat Pruritis in Hemodialysis Patients (CRN11)
Primary Purpose
Pruritis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
50,000 Units Ergocalciferol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pruritis focused on measuring Pruritis in hemodialysis patients, 25-Vitamin D in chronic kidney disease
Eligibility 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
Sites / Locations
- Winthop Univ Hospital Outpatient Dialysis at Bethpage
- Winthrop Univ Hospital Outpatient Dialysis
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ergocalciferol
oral placebo
Arm Description
Outcomes
Primary Outcome Measures
Severity of Pruritis
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01114672
First Posted
April 29, 2010
Last Updated
February 15, 2013
Sponsor
Winthrop University Hospital
Collaborators
National Kidney Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01114672
Brief Title
A Study of Oral Ergocalciferol to Treat Pruritis in Hemodialysis Patients
Acronym
CRN11
Official Title
A Randomized Prospective, Double-Blind Placebo Controlled Study of Oral Ergocalciferol in the Treatment of Pruritis in Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Winthrop University Hospital
Collaborators
National Kidney Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritis
Keywords
Pruritis in hemodialysis patients, 25-Vitamin D in chronic kidney disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ergocalciferol
Arm Type
Active Comparator
Arm Title
oral placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
50,000 Units Ergocalciferol
Intervention Description
50,000 Units oral ergocalciferol to be given once weekly
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral placebo once weekly
Primary Outcome Measure Information:
Title
Severity of Pruritis
Description
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.
Time Frame
Baseline and end of study (up to 12 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Fishbane, MD
Organizational Affiliation
Department of Nephrology, Winthrop Univ Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mary Schanler, MS, RD
Organizational Affiliation
Winthrop University Hospital, Outpatient Dialysis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Winthop Univ Hospital Outpatient Dialysis at Bethpage
City
Bethpage
State/Province
New York
ZIP/Postal Code
11714
Country
United States
Facility Name
Winthrop Univ Hospital Outpatient Dialysis
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33283264
Citation
Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
Results Reference
derived
PubMed Identifier
23453391
Citation
Shirazian S, Schanler M, Shastry S, Dwivedi S, Kumar M, Rice K, Miyawaki N, Ghosh S, Fishbane S. The effect of ergocalciferol on uremic pruritus severity: a randomized controlled trial. J Ren Nutr. 2013 Jul;23(4):308-14. doi: 10.1053/j.jrn.2012.12.007. Epub 2013 Feb 27.
Results Reference
derived
Learn more about this trial
A Study of Oral Ergocalciferol to Treat Pruritis in Hemodialysis Patients
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