Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients
Last updated on August 2021Recruitment
- Recruitment Status
- Completed
Summary
- Conditions
- Anemia
- Bone Diseases, Metabolic
- Kidney Failure Chronic
- Vitamin D Deficiency
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: Randomized\nIntervention Model: Parallel Assignment\nMasking: Triple (Participant, Care Provider, Outcomes Assessor)\nPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 20 years and 125 years
- Gender
- Both males and females
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) Monthly placebo. The primary analyses will be done regarding 2 cholecalciferol groups and 2 placebo...
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) Monthly placebo. The primary analyses will be done regarding 2 cholecalciferol groups and 2 placebo groups as one group each, and we will evaluate the effect of cholecalciferol regardless of the supplementation regimen. As the secondary analyses, we will examine if there is any difference between thrice-weekly and once-monthly supplementation regimen.
Tracking Information
- NCT #
- NCT02214563
- Collaborators
- Obi clinic
- The Japan Kidney Foundation
- Molecular Physiological Chemistry Laboratory, Inc.
- Higashikouri Hospital
- Nishi clinic
- Futaba clinic
- Akebono clinic
- The Japan Kidney Foundation
- Obi clinic
- Higashikouri Hospital
- Futaba clinic
- Akebono clinic
- Molecular Physiological Chemistry Laboratory, Inc.
- Nishi clinic
- Investigators
- Study Chair: Yoshiharu Tsubakihara, MD, PhD Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine
- Study Chair: Yoshiharu Tsubakihara, MD, PhD Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine
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