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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014819

Enrollment

Registered

2014-08-15

Start date

2014-08-14

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

End-stage renal disease requiring hemodialysis

Interventions

Thrice-weekly cholecalciferol (3,000 IU) supplementation Thrice-weekly placebo Monthly cholecalciferol supplementation equivalent to 9,000 IU/week Monthly placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with end-stage renal disease receiving thrice-weekly maintenance hemodialysis 2) On treatment with erythropoietin stimulating agent 3) With written informed concent

Exclusion criteria

Exclusion criteria: 1) On treatment with epoetin beta pegol as ESA 2) On supplementation with native vitamin D 3) Hypercalcemia (>=10.5 mg/dL ofcorrected serum calcium) 4) On treatment with intravenous iron agents 5) Judged as ineligible to the randomized study by the investigators

Design outcomes

Primary

Measure	Time frame
Serum hepcidin-25 concentrations at day 3 and the 3rd month	—

Secondary

Measure	Time frame
1) Serum hepcidin-25 concentrations at the 6th month 2) Percent change of ERI (erythropoietin resistance index) overtime (up to the 6th month) * ERI = Average weekly dose of ESA over prior 4 weeks / post-dialysis body weight (kg) / Hb (g/dL) 3) Blood concentrations of calcium, phosphate, and intact parathyroid hormone overtime (up to the 6th month) 4) Blood concentrations of high-sensitive CRP, IL-6, and TNF-alpha at day 3, the 3rd month, and the 6th month 5) Blood concentrations of 1,25-dihydroxyvitamin D, bone specific alkaline phosphatase, and tartrate-resistant acid phosphatase (TRAcP) 5b at the 3rd months and the 6th month	—

Measure

Time frame

1) Serum hepcidin-25 concentrations at the 6th month 2) Percent change of ERI (erythropoietin resistance index) overtime (up to the 6th month) * ERI = Average weekly dose of ESA over prior 4 weeks / post-dialysis body weight (kg) / Hb (g/dL) 3) Blood concentrations of calcium, phosphate, and intact parathyroid hormone overtime (up to the 6th month) 4) Blood concentrations of high-sensitive CRP, IL-6, and TNF-alpha at day 3, the 3rd month, and the 6th month 5) Blood concentrations of 1,25-dihydroxyvitamin D, bone specific alkaline phosphatase, and tartrate-resistant acid phosphatase (TRAcP) 5b at the 3rd months and the 6th month

—

Countries

Japan

Contacts

Public ContactTakayuki Hamano

Osaka University Graduate School of Medicine Department of Comprehensive Kidney Disease Research

hamatea@kid.med.osaka-u.ac.jp06-6879-3857

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026