Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients (CHAMBER)

Takayuki Hamano

Status and phase

Completed

Phase 4

Conditions

Anemia

Vitamin D Deficiency

Bone Diseases, Metabolic

Kidney Failure, Chronic

Treatments

Dietary Supplement: Cholecalciferol

Dietary Supplement: Olive oil

Study type

Interventional

Funder types

Other

Identifiers

NCT02214563

CKDR-003

Details and patient eligibility

About

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

Full 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 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.

Enrollment

90 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

90 participants in 4 patient groups, including a placebo group

Thrice-weekly cholecalciferol

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Cholecalciferol

Monthly cholecalciferol

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Cholecalciferol

Thrice-weekly placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Olive oil

Monthly placebo

Placebo Comparator group

Description:

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