Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients (CHAMBER)

August 29, 2018 updated by: Takayuki Hamano

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kumamoto, Japan, 861-4112
        • Akebono Clinic
      • Osaka, Japan, 543-0052
        • Obi clinic
      • Osaka, Japan, 552-0007
        • Nishi clinic
      • Osaka, Japan, 559-0013
        • Futaba Clinic
    • Hyogo
      • Nishinomiya, Hyogo, Japan, 662-0918
        • Hyogo Prefectural Nishinomiya Hospital
    • Osaka
      • Hirakata, Osaka, Japan, 573-0075
        • Higashikouri hospital
      • Suita, Osaka, Japan, 565-0871
        • Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Thrice-weekly cholecalciferol
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.
Dietary supplement: Cholecalciferol
Made for this trial by Molecular Physiological Chemistry Laboratory, Inc.
Other Names:
  • vitamin D
  • vitamin D3
Active Comparator: Monthly cholecalciferol
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.
Dietary supplement: Cholecalciferol
Made for this trial by Molecular Physiological Chemistry Laboratory, Inc.
Other Names:
  • vitamin D
  • vitamin D3
Placebo Comparator: Thrice-weekly placebo
Olive oil coated by soft capsule made of gelatin and glycerin.
Dietary supplement: Olive oil
Placebo Comparator: Monthly placebo
Olive oil coated by soft capsule made of gelatin and glycerin.
Dietary supplement: Olive oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum concentrations of hepcidin-25
Time Frame: The 3rd month
The 3rd month
Serum concentrations of hepcidin-25
Time Frame: The 3rd day
The 3rd day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum concentrations of hepcidin-25
Time Frame: The 6th month
The 6th month
Percent change of erythropoietin resistance index (ERI) overtime
Time Frame: Up to the 6th month
ERI = Average weekly dose of erythropoiesis-stimulating agents (ESA) over prior 4 weeks / post-dialysis body weight (kg) / Hb (g/dL)
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
In the secondary analysis, we will adjust baseline concentrations when comparing the groups.
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
In the secondary analysis, we will adjust baseline concentrations when comparing the groups.
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
In the secondary analysis, we will adjust baseline concentrations when comparing the groups.
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
In the secondary analysis, we will adjust baseline concentrations when comparing the groups.
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
In the secondary analysis, we will adjust baseline concentrations when comparing the groups.
The 6th month
Blood concentrations of calcium, phosphate, and intact parathyroid hormone overtime
Time Frame: Up to the 6th month
In the secondary analysis, we will adjust baseline concentrations when comparing the groups.
Up to the 6th month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypercalcemia
Time Frame: Up to the 6th month
>=10.5 mg/dL of albumin corrected calcium
Up to the 6th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takayuki Hamano

Collaborators

The Japan Kidney Foundation
Molecular Physiological Chemistry Laboratory, Inc.
Obi clinic
Higashikouri Hospital
Nishi clinic
Futaba clinic
Akebono clinic

Investigators

  • Study Chair: Yoshiharu Tsubakihara, MD, PhD, Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

August 10, 2014

First Submitted That Met QC Criteria

August 11, 2014

First Posted (Estimate)

August 12, 2014

Study Record Updates

Last Update Posted (Actual)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 29, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CKDR-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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