Status:
COMPLETED
Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients
Lead Sponsor:
Takayuki Hamano
Collaborating Sponsors:
The Japan Kidney Foundation
Molecular Physiological Chemistry Laboratory, Inc.
Conditions:
Kidney Failure, Chronic
Anemia
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether cholecalciferol supplementation decrease the blood concentrations of hepcidin-25 in hemodialysis patients.
Detailed Description
There are 4 arms in this study: (1) Thrice-weekly cholecalciferol supplementation (3,000 IU), (2) Monthly cholecalciferol supplementation (equivalent to 9,000/week), (3) Thrice-weekly placebo, and (4)...
Eligibility Criteria
Inclusion
- Patients with end-stage renal disease receiving thrice-weekly maintenance hemodialysis
- On treatment with erythropoietin stimulating agent
- With written informed consent
Exclusion
- On treatment with epoetin beta pegol as ESA
- On supplementation with native vitamin D
- Hypercalcemia (\>=10.5 mg/dL of corrected serum calcium)
- On treatment with intravenous iron agents
- Judged as ineligible to the randomized study by the investigators
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT02214563
Start Date
August 1 2014
End Date
December 1 2016
Last Update
August 31 2018
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Hyogo Prefectural Nishinomiya Hospital
Nishinomiya, Hyōgo, Japan, 662-0918
2
Higashikouri hospital
Hirakata, Osaka, Japan, 573-0075
3
Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine
Suita, Osaka, Japan, 565-0871
4
Akebono clinic
Kumamoto, Japan, 861-4112