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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02214563

Acronym

CHAMBER

Enrollment

Registered

2014-08-12

Start date

2014-08-31

Completion date

2016-12-31

Last updated

2018-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Bone Diseases, Metabolic, Kidney Failure, Chronic, Vitamin D Deficiency

Keywords

Vitamin D, Cholecalciferol, Hepcidins, Renal Dialysis

Brief summary

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

Detailed 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.

Interventions

DIETARY_SUPPLEMENTCholecalciferol

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

DIETARY_SUPPLEMENTOlive oil

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Serum concentrations of hepcidin-25	The 3rd month

Secondary

Measure	Time frame	Description
Serum concentrations of hepcidin-25	The 6th month	—
Percent change of erythropoietin resistance index (ERI) overtime	Up to the 6th month	ERI = Average weekly dose of erythropoiesis-stimulating agents (ESA) over prior 4 weeks / post-dialysis body weight (kg) / Hb (g/dL)
Blood concentrations of high-sensitive C reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-alpha	The 3rd day	In the secondary analysis, we will adjust baseline concentrations when comparing the groups.
Blood concentrations of calcium, phosphate, and intact parathyroid hormone overtime	Up to the 6th month	In the secondary analysis, we will adjust baseline concentrations when comparing the groups.
Blood concentrations of 1,25-dihydroxyvitamin D, bone specific alkaline phosphatase (BAP), and tartrate-resistant acid phosphatase (TRAcP) 5b	The 3rd month	In the secondary analysis, we will adjust baseline concentrations when comparing the groups.

Other

Measure	Time frame	Description
Hypercalcemia	Up to the 6th month	\>=10.5 mg/dL of albumin corrected calcium

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026