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

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

Detailed Description
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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.

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

Conditions
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Kidney Failure, Chronic, Anemia, Vitamin D Deficiency, Bone Diseases, Metabolic

Intervention / Treatment
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* Dietary Supplement: Cholecalciferol
* Dietary Supplement: Olive oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Thrice-weekly cholecalciferol<br>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<br>* Made for this trial by Molecular Physiological Chemistry Laboratory, Inc.<br>* Other names: vitamin D3;|
| Active Comparator: Monthly cholecalciferol<br>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<br>* Made for this trial by Molecular Physiological Chemistry Laboratory, Inc.<br>* Other names: vitamin D3;|
| Placebo Comparator: Thrice-weekly placebo<br>Olive oil coated by soft capsule made of gelatin and glycerin. | Dietary Supplement: Olive oil<br> <br> |
| Placebo Comparator: Monthly placebo<br>Olive oil coated by soft capsule made of gelatin and glycerin. | Dietary Supplement: Olive oil<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentrations of hepcidin-25 |  | The 6th month | 
| 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) | Up to the 6th month | 
| 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. | The 3rd month | 
| 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. | The 6th month | 
| 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. | The 3rd day | 
| 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. | The 3rd month | 
| 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. | The 6th month | 
| Blood concentrations of calcium, phosphate, and intact parathyroid hormone overtime | In the secondary analysis, we will adjust baseline concentrations when comparing the groups. | Up to the 6th month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Cholecalciferol, Hepcidins, Renal Dialysis