Trial | NCT02214563  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    90
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.
Study Started
Aug 31
2014
Primary Completion
Mar 31
2016
Study Completion
Dec 31
2016
Last Update
Aug 31
2018

Dietary Supplement Cholecalciferol

Made for this trial by Molecular Physiological Chemistry Laboratory, Inc.

  • Other names: vitamin D, vitamin D3

Dietary Supplement Olive oil

Thrice-weekly cholecalciferol Active Comparator

Capsule containing 3,000 IU of cholecalciferol will be given at the end of each hemodialysis session. Dissolved with olive oil and coated by soft capsule made of gelatin and glycerin.

Monthly cholecalciferol Active Comparator

Capsules containing a dose equivalent to 9,000 IU/week will be given at the end of the first hemodialysis session in the 3rd week of each month. Dissolved with olive oil and coated by soft capsule made of gelatin and glycerin.

Thrice-weekly placebo Placebo Comparator

Olive oil coated by soft capsule made of gelatin and glycerin.

Monthly placebo Placebo Comparator

Olive oil coated by soft capsule made of gelatin and glycerin.

Criteria 

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
No Results Posted