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

Primary Purpose

Kidney Failure, Chronic, Anemia, Vitamin D Deficiency

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Cholecalciferol
Olive oil
Sponsored by
Takayuki Hamano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure, Chronic focused on measuring Vitamin D, Cholecalciferol, Hepcidins, Renal Dialysis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hyogo Prefectural Nishinomiya Hospital
  • Higashikouri hospital
  • Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine
  • Akebono clinic
  • Obi clinic
  • Nishi clinic
  • Futaba clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Thrice-weekly cholecalciferol

Monthly cholecalciferol

Thrice-weekly placebo

Monthly placebo

Arm Description

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.

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.

Olive oil coated by soft capsule made of gelatin and glycerin.

Olive oil coated by soft capsule made of gelatin and glycerin.

Outcomes

Primary Outcome Measures

Serum concentrations of hepcidin-25
Serum concentrations of hepcidin-25

Secondary Outcome Measures

Serum concentrations of hepcidin-25
Percent change of erythropoietin resistance index (ERI) overtime
ERI = Average weekly dose of erythropoiesis-stimulating agents (ESA) over prior 4 weeks / post-dialysis body weight (kg) / Hb (g/dL)
Blood concentrations of 1,25-dihydroxyvitamin D, bone specific alkaline phosphatase (BAP), and tartrate-resistant acid phosphatase (TRAcP) 5b
In the secondary analysis, we will adjust baseline concentrations when comparing the groups.
Blood concentrations of 1,25-dihydroxyvitamin D, bone specific alkaline phosphatase (BAP), and tartrate-resistant acid phosphatase (TRAcP) 5b
In the secondary analysis, we will adjust baseline concentrations when comparing the groups.
Blood concentrations of high-sensitive C reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-alpha
In the secondary analysis, we will adjust baseline concentrations when comparing the groups.
Blood concentrations of high-sensitive C reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-alpha
In the secondary analysis, we will adjust baseline concentrations when comparing the groups.
Blood concentrations of high-sensitive C reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-alpha
In the secondary analysis, we will adjust baseline concentrations when comparing the groups.
Blood concentrations of calcium, phosphate, and intact parathyroid hormone overtime
In the secondary analysis, we will adjust baseline concentrations when comparing the groups.

Full Information

First Posted
August 10, 2014
Last Updated
August 29, 2018
Sponsor
Takayuki Hamano
Collaborators
The Japan Kidney Foundation, Molecular Physiological Chemistry Laboratory, Inc., Obi clinic, Higashikouri Hospital, Nishi clinic, Futaba clinic, Akebono clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02214563
Brief Title
Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients
Acronym
CHAMBER
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Takayuki Hamano
Collaborators
The Japan Kidney Foundation, Molecular Physiological Chemistry Laboratory, Inc., Obi clinic, Higashikouri Hospital, Nishi clinic, Futaba clinic, Akebono clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic, Anemia, Vitamin D Deficiency, Bone Diseases, Metabolic
Keywords
Vitamin D, Cholecalciferol, Hepcidins, Renal Dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thrice-weekly cholecalciferol
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Monthly cholecalciferol
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Thrice-weekly placebo
Arm Type
Placebo Comparator
Arm Description
Olive oil coated by soft capsule made of gelatin and glycerin.
Arm Title
Monthly placebo
Arm Type
Placebo Comparator
Arm Description
Olive oil coated by soft capsule made of gelatin and glycerin.
Intervention Type
Dietary Supplement
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
vitamin D, vitamin D3
Intervention Description
Made for this trial by Molecular Physiological Chemistry Laboratory, Inc.
Intervention Type
Dietary Supplement
Intervention Name(s)
Olive oil
Primary Outcome Measure Information:
Title
Serum concentrations of hepcidin-25
Time Frame
The 3rd month
Title
Serum concentrations of hepcidin-25
Time Frame
The 3rd day
Secondary Outcome Measure Information:
Title
Serum concentrations of hepcidin-25
Time Frame
The 6th month
Title
Percent change of erythropoietin resistance index (ERI) overtime
Description
ERI = Average weekly dose of erythropoiesis-stimulating agents (ESA) over prior 4 weeks / post-dialysis body weight (kg) / Hb (g/dL)
Time Frame
Up to the 6th month
Title
Blood concentrations of 1,25-dihydroxyvitamin D, bone specific alkaline phosphatase (BAP), and tartrate-resistant acid phosphatase (TRAcP) 5b
Description
In the secondary analysis, we will adjust baseline concentrations when comparing the groups.
Time Frame
The 3rd month
Title
Blood concentrations of 1,25-dihydroxyvitamin D, bone specific alkaline phosphatase (BAP), and tartrate-resistant acid phosphatase (TRAcP) 5b
Description
In the secondary analysis, we will adjust baseline concentrations when comparing the groups.
Time Frame
The 6th month
Title
Blood concentrations of high-sensitive C reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-alpha
Description
In the secondary analysis, we will adjust baseline concentrations when comparing the groups.
Time Frame
The 3rd day
Title
Blood concentrations of high-sensitive C reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-alpha
Description
In the secondary analysis, we will adjust baseline concentrations when comparing the groups.
Time Frame
The 3rd month
Title
Blood concentrations of high-sensitive C reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-alpha
Description
In the secondary analysis, we will adjust baseline concentrations when comparing the groups.
Time Frame
The 6th month
Title
Blood concentrations of calcium, phosphate, and intact parathyroid hormone overtime
Description
In the secondary analysis, we will adjust baseline concentrations when comparing the groups.
Time Frame
Up to the 6th month
Other Pre-specified Outcome Measures:
Title
Hypercalcemia
Description
>=10.5 mg/dL of albumin corrected calcium
Time Frame
Up to the 6th month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshiharu Tsubakihara, MD, PhD
Organizational Affiliation
Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Hyogo Prefectural Nishinomiya Hospital
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
662-0918
Country
Japan
Facility Name
Higashikouri hospital
City
Hirakata
State/Province
Osaka
ZIP/Postal Code
573-0075
Country
Japan
Facility Name
Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Akebono clinic
City
Kumamoto
ZIP/Postal Code
861-4112
Country
Japan
Facility Name
Obi clinic
City
Osaka
ZIP/Postal Code
543-0052
Country
Japan
Facility Name
Nishi clinic
City
Osaka
ZIP/Postal Code
552-0007
Country
Japan
Facility Name
Futaba clinic
City
Osaka
ZIP/Postal Code
559-0013
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
32968158
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.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/24204002
Description
Link to the report which showed the negative effect of vitamin D on blood hepcidin-25 concentration in human subjects

Learn more about this trial

Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients

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