Clinical trial NCT02214563: Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients
Official title: Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients (CHAMBER): A Multicenter, Double-blind, Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Failure, Chronic
Anemia
Vitamin D Deficiency
Bone Diseases, Metabolic
Keywords: Vitamin D
Cholecalciferol
Hepcidins
Renal Dialysis
Lead sponsor: Osaka University
Sponsor class: OTHER
Collaborators: name: The Japan Kidney Foundation
name: Molecular Physiological Chemistry Laboratory, Inc.
name: Obi clinic
name: Higashikouri Hospital
name: Nishi clinic
name: Futaba clinic
name: Akebono clinic
First posted: 2014-08-12
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Serum concentrations of hepcidin-25
timeFrame: The 3rd month
measure: Serum concentrations of hepcidin-25
timeFrame: The 3rd day
Secondary outcomes:
measure: Serum concentrations of hepcidin-25
timeFrame: The 6th month
measure: Percent change of erythropoietin resistance index (ERI) overtime
timeFrame: Up to the 6th month
measure: Blood concentrations of 1,25-dihydroxyvitamin D, bone specific alkaline phosphatase (BAP), and tartrate-resistant acid phosphatase (TRAcP) 5b
timeFrame: The 3rd month
measure: Blood concentrations of 1,25-dihydroxyvitamin D, bone specific alkaline phosphatase (BAP), and tartrate-resistant acid phosphatase (TRAcP) 5b
timeFrame: The 6th month
measure: Blood concentrations of high-sensitive C reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-alpha
timeFrame: The 3rd day
measure: Blood concentrations of high-sensitive C reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-alpha
timeFrame: The 3rd month
measure: Blood concentrations of high-sensitive C reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-alpha
timeFrame: The 6th month
measure: Blood concentrations of calcium, phosphate, and intact parathyroid hormone overtime
timeFrame: Up to the 6th month
Other outcomes:
measure: Hypercalcemia
timeFrame: Up to the 6th month
Locations:
city: Nishinomiya
country: Japan
facility: Hyogo Prefectural Nishinomiya Hospital
state: Hyogo
city: Hirakata
country: Japan
facility: Higashikouri hospital
state: Osaka
city: Suita
country: Japan
facility: Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine
state: Osaka
city: Kumamoto
country: Japan
facility: Akebono clinic
city: Osaka
country: Japan
facility: Obi clinic
city: Osaka
country: Japan
facility: Nishi clinic
city: Osaka
country: Japan
facility: Futaba clinic
Study officials:
affiliation: Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine
name: Yoshiharu Tsubakihara, MD, PhD
role: STUDY_CHAIR
References:
citation: Obi Y, Yamaguchi S, Hamano T, Sakaguchi Y, Shimomura A, Namba-Hamano T, Mikami S, Nishi O, Tanaka M, Kamoto A, Obi Y, Tomosugi N, Tsubakihara Y, Isaka Y. Effect of cholecalciferol on serum hepcidin and parameters of anaemia and CKD-MBD among haemodialysis patients: a randomized clinical trial. Sci Rep. 2020 Sep 23;10(1):15500. doi: 10.1038/s41598-020-72385-w.