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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02214563
Recruitment Status : Completed
First Posted : August 12, 2014
Last Update Posted : August 31, 2018
Sponsor:
Collaborators:
The Japan Kidney Foundation
Molecular Physiological Chemistry Laboratory, Inc.
Obi clinic
Higashikouri Hospital
Nishi clinic
Futaba clinic
Akebono clinic
Information provided by (Responsible Party):
Takayuki Hamano, Osaka University

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

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Anemia Vitamin D Deficiency Bone Diseases, Metabolic Dietary Supplement: Cholecalciferol Dietary Supplement: Olive oil Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients (CHAMBER): A Multicenter, Double-blind, Randomized, Placebo-controlled Trial
Actual Study Start Date : August 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Serum concentrations of hepcidin-25 [ Time Frame: The 3rd month ]
  2. Serum concentrations of hepcidin-25 [ Time Frame: The 3rd day ]

Secondary Outcome Measures :
  1. Serum concentrations of hepcidin-25 [ Time Frame: The 6th month ]
  2. 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)

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Other Outcome Measures:
  1. Hypercalcemia [ Time Frame: Up to the 6th month ]
    >=10.5 mg/dL of albumin corrected calcium


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214563


Locations
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Japan
Hyogo Prefectural Nishinomiya Hospital
Nishinomiya, Hyogo, Japan, 662-0918
Higashikouri hospital
Hirakata, Osaka, Japan, 573-0075
Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine
Suita, Osaka, Japan, 565-0871
Akebono clinic
Kumamoto, Japan, 861-4112
Obi clinic
Osaka, Japan, 543-0052
Nishi clinic
Osaka, Japan, 552-0007
Futaba clinic
Osaka, Japan, 559-0013
Sponsors and Collaborators
Takayuki Hamano
The Japan Kidney Foundation
Molecular Physiological Chemistry Laboratory, Inc.
Obi clinic
Higashikouri Hospital
Nishi clinic
Futaba clinic
Akebono clinic
Investigators
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Study Chair: Yoshiharu Tsubakihara, MD, PhD Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Takayuki Hamano, Associate Professor, Osaka University
ClinicalTrials.gov Identifier: NCT02214563    
Other Study ID Numbers: CKDR-003
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Keywords provided by Takayuki Hamano, Osaka University:
Vitamin D
Cholecalciferol
Hepcidins
Renal Dialysis
Additional relevant MeSH terms:
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Bone Diseases
Bone Diseases, Metabolic
Renal Insufficiency
Kidney Failure, Chronic
Anemia
Vitamin D Deficiency
Metabolic Diseases
Hematologic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
 Kidney Diseases
Urologic Diseases
Musculoskeletal Diseases
Renal Insufficiency, Chronic
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents