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

Sponsor

Takayuki Hamano (Other)

Overall Status

Completed

CT.gov ID

NCT02214563

Collaborator

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

Enrollment

Locations

Arms

Actual Duration (Months)

12.9

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

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

Study Type:

Interventional

Anticipated 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 :

Aug 1, 2014

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

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

Primary Outcome Measures

Serum concentrations of hepcidin-25 [The 3rd month]
Serum concentrations of hepcidin-25 [The 3rd day]

Secondary Outcome Measures

Serum concentrations of hepcidin-25 [The 6th month]
Percent change of erythropoietin resistance index (ERI) overtime [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)
Blood concentrations of 1,25-dihydroxyvitamin D, bone specific alkaline phosphatase (BAP), and tartrate-resistant acid phosphatase (TRAcP) 5b [The 3rd month]
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 [The 6th month]
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 [The 3rd day]
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 [The 3rd month]
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 [The 6th month]
In the secondary analysis, we will adjust baseline concentrations when comparing the groups.
Blood concentrations of calcium, phosphate, and intact parathyroid hormone overtime [Up to the 6th month]
In the secondary analysis, we will adjust baseline concentrations when comparing the groups.

Other Outcome Measures

Hypercalcemia [Up to the 6th month]
>=10.5 mg/dL of albumin corrected calcium

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hyogo Prefectural Nishinomiya Hospital	Nishinomiya	Hyogo	Japan	662-0918
2	Higashikouri hospital	Hirakata	Osaka	Japan	573-0075
3	Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine	Suita	Osaka	Japan	565-0871
4	Akebono clinic	Kumamoto		Japan	861-4112
5	Obi clinic	Osaka		Japan	543-0052
6	Nishi clinic	Osaka		Japan	552-0007
7	Futaba clinic	Osaka		Japan	559-0013