Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients
- Conditions
- Vitamin D DeficiencyKidney Failure, ChronicBone Diseases, MetabolicAnemia
- Interventions
- Dietary Supplement: CholecalciferolDietary Supplement: Olive oil
- Registration Number
- NCT02214563
- Lead Sponsor
- Takayuki Hamano
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- Patients with end-stage renal disease receiving thrice-weekly maintenance hemodialysis
- On treatment with erythropoietin stimulating agent
- With written informed consent
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Monthly cholecalciferol 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. Monthly placebo Olive oil Olive oil coated by soft capsule made of gelatin and glycerin. Thrice-weekly cholecalciferol 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. Thrice-weekly placebo Olive oil Olive oil coated by soft capsule made of gelatin and glycerin.
- Primary Outcome Measures
Name Time Method Serum concentrations of hepcidin-25 The 3rd day
- Secondary Outcome Measures
Name Time Method 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 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 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.
Trial Locations
- Locations (7)
Hyogo Prefectural Nishinomiya Hospital
🇯🇵Nishinomiya, Hyogo, Japan
Akebono clinic
🇯🇵Kumamoto, Japan
Nishi clinic
🇯🇵Osaka, Japan
Futaba clinic
🇯🇵Osaka, Japan
Higashikouri hospital
🇯🇵Hirakata, Osaka, Japan
Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine
🇯🇵Suita, Osaka, Japan
Obi clinic
🇯🇵Osaka, Japan