Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients
CHAMBER
1 other identifier
interventional
90
1 country
7
Brief Summary
The purpose of this study is to determine whether cholecalciferol supplementation decrease the blood concentrations of hepcidin-25 in hemodialysis patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2014
Typical duration for phase_4
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 10, 2014
CompletedFirst Posted
Study publicly available on registry
August 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedAugust 31, 2018
August 1, 2018
1.6 years
August 10, 2014
August 29, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Serum concentrations of hepcidin-25
The 3rd month
Serum concentrations of hepcidin-25
The 3rd day
Secondary Outcomes (8)
Serum concentrations of hepcidin-25
The 6th month
Percent change of erythropoietin resistance index (ERI) overtime
Up to the 6th month
Blood concentrations of 1,25-dihydroxyvitamin D, bone specific alkaline phosphatase (BAP), and tartrate-resistant acid phosphatase (TRAcP) 5b
The 3rd month
Blood concentrations of 1,25-dihydroxyvitamin D, bone specific alkaline phosphatase (BAP), and tartrate-resistant acid phosphatase (TRAcP) 5b
The 6th month
Blood concentrations of high-sensitive C reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-alpha
The 3rd day
- +3 more secondary outcomes
Other Outcomes (1)
Hypercalcemia
Up to the 6th month
Study Arms (4)
Thrice-weekly cholecalciferol
ACTIVE COMPARATORCapsule 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 COMPARATORCapsules 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 COMPARATOROlive oil coated by soft capsule made of gelatin and glycerin.
Monthly placebo
PLACEBO COMPARATOROlive oil coated by soft capsule made of gelatin and glycerin.
Interventions
Made for this trial by Molecular Physiological Chemistry Laboratory, Inc.
Eligibility Criteria
You may qualify if:
- Patients with end-stage renal disease receiving thrice-weekly maintenance hemodialysis
- On treatment with erythropoietin stimulating agent
- With written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takayuki Hamanolead
- The Japan Kidney Foundationcollaborator
- Molecular Physiological Chemistry Laboratory, Inc.collaborator
- Obi cliniccollaborator
- Higashikouri Hospitalcollaborator
- Nishi cliniccollaborator
- Futaba cliniccollaborator
- Akebono cliniccollaborator
Study Sites (7)
Hyogo Prefectural Nishinomiya Hospital
Nishinomiya, Hyōgo, 662-0918, Japan
Higashikouri hospital
Hirakata, Osaka, 573-0075, Japan
Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine
Suita, Osaka, 565-0871, Japan
Akebono clinic
Kumamoto, 861-4112, Japan
Obi clinic
Osaka, 543-0052, Japan
Nishi clinic
Osaka, 552-0007, Japan
Futaba clinic
Osaka, 559-0013, Japan
Related Publications (1)
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.
PMID: 32968158DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yoshiharu Tsubakihara, MD, PhD
Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 10, 2014
First Posted
August 12, 2014
Study Start
August 1, 2014
Primary Completion
March 1, 2016
Study Completion
December 1, 2016
Last Updated
August 31, 2018
Record last verified: 2018-08