Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients

Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients (CHAMBER): A Multicenter, Double-blind, Randomized, Placebo-controlled Trial

The purpose of this study is to determine whether cholecalciferol supplementation decrease the blood concentrations of hepcidin-25 in hemodialysis patients.

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.

Inclusion Criteria:

• Patients with end-stage renal disease receiving thrice-weekly maintenance hemodialysis
• On treatment with erythropoietin stimulating agent
• With written informed consent

Exclusion Criteria:

• 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