Overview

This trial is active, not recruiting.

Conditions kidney failure, chronic, anemia, vitamin d deficiency, bone diseases, metabolic
Treatments cholecalciferol, olive oil
Phase phase 4
Sponsor Yoshiharu Tsubakihara
Collaborator The Japan Kidney Foundation
Start date August 2014
End date March 2016
Trial size 90 participants
Trial identifier NCT02214563, CKDR-003

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Capsule 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.
cholecalciferol vitamin D
Made for this trial by Molecular Physiological Chemistry Laboratory, Inc.
(Active Comparator)
Capsules 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.
cholecalciferol vitamin D
Made for this trial by Molecular Physiological Chemistry Laboratory, Inc.
(Placebo Comparator)
Olive oil coated by soft capsule made of gelatin and glycerin.
olive oil
(Placebo Comparator)
Olive oil coated by soft capsule made of gelatin and glycerin.
olive oil

Primary Outcomes

Measure
Serum concentrations of hepcidin-25
time frame: The 3rd month
Serum concentrations of hepcidin-25
time frame: The 3rd day

Secondary Outcomes

Measure
Serum concentrations of hepcidin-25
time frame: The 6th month
Percent change of erythropoietin resistance index (ERI) overtime
time frame: Up to the 6th month
Blood concentrations of 1,25-dihydroxyvitamin D, bone specific alkaline phosphatase (BAP), and tartrate-resistant acid phosphatase (TRAcP) 5b
time frame: The 3rd month
Blood concentrations of 1,25-dihydroxyvitamin D, bone specific alkaline phosphatase (BAP), and tartrate-resistant acid phosphatase (TRAcP) 5b
time frame: The 6th month
Blood concentrations of high-sensitive C reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-alpha
time frame: The 3rd day
Blood concentrations of high-sensitive C reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-alpha
time frame: The 3rd month
Blood concentrations of high-sensitive C reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-alpha
time frame: The 6th month
Blood concentrations of calcium, phosphate, and intact parathyroid hormone overtime
time frame: Up to the 6th month

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients (CHAMBER): A Multicenter, Double-blind, Randomized, Placebo-controlled Trial
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Osaka University.