Recruitment

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
  • Obi clinic
  • Nishi clinic
  • Futaba clinic
  • Akebono clinic
  • The Japan Kidney Foundation
  • Nishi clinic
  • Futaba clinic
  • Akebono clinic
  • Higashikouri Hospital
  • Molecular Physiological Chemistry Laboratory, Inc.
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