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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000014819 |
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Date of registration:
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15/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients (CHAMBER): A Multicenter, Double-blind, Randomized, Placebo-controlled Trial
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Scientific title:
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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) |
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Date of first enrolment:
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2014/08/14 |
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Target sample size:
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90 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017152 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Phase IV
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Countries of recruitment
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Japan
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Contacts
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Name:
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Takayuki Hamano |
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Address:
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2-2, Yamada-oka, Suita, Osaka, Japan
Japan |
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Telephone:
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06-6879-3857 |
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Email:
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tsubakihara@kid.med.osaka-u.ac.jp |
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Affiliation:
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Osaka University Graduate School of Medicine Department of Comprehensive Kidney Disease Research |
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Name:
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Takayuki Hamano |
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Address:
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2-2, Yamada-oka, Suita, Osaka, Japan
Japan |
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Telephone:
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06-6879-3857 |
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Email:
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hamatea@kid.med.osaka-u.ac.jp |
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Affiliation:
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Osaka University Graduate School of Medicine Department of Comprehensive Kidney Disease Research |
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Key inclusion & exclusion criteria
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Inclusion 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
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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End-stage renal disease requiring hemodialysis
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Intervention(s)
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Thrice-weekly cholecalciferol (3,000 IU) supplementation
Thrice-weekly placebo
Monthly cholecalciferol supplementation equivalent to 9,000 IU/week
Monthly placebo
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Primary Outcome(s)
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Serum hepcidin-25 concentrations at day 3 and the 3rd month
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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Grant for pathophysiological research conference in chronic kidney disease
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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30/04/2016 |
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URL:
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