Cholecalciferol Supplementation for Anemia and Mineral and Bone Disorder in Hemodialysis Patients (CHAMBER): A Multicenter, Double-blind, Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 14
- 主要终点
- Serum concentrations of hepcidin-25
研究概览
简要总结
The purpose of this study is to determine whether cholecalciferol supplementation decrease the blood concentrations of hepcidin-25 in hemodialysis patients.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with end-stage renal disease receiving thrice-weekly maintenance hemodialysis
- •On treatment with erythropoietin stimulating agent
- •With written informed consent
排除标准
- •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
研究组 & 干预措施
Monthly placebo
Olive oil coated by soft capsule made of gelatin and glycerin.
干预措施: Olive oil (Dietary Supplement)
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.
干预措施: Cholecalciferol (Dietary Supplement)
Thrice-weekly placebo
Olive oil coated by soft capsule made of gelatin and glycerin.
干预措施: Olive oil (Dietary Supplement)
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.
干预措施: Cholecalciferol (Dietary Supplement)
结局指标
主要结局
Serum concentrations of hepcidin-25
时间窗: The 3rd day
次要结局
- Blood concentrations of calcium, phosphate, and intact parathyroid hormone overtime(Up to the 6th month)
- Serum concentrations of hepcidin-25(The 6th month)
- Percent change of erythropoietin resistance index (ERI) overtime(Up to the 6th month)
- Blood concentrations of 1,25-dihydroxyvitamin D, bone specific alkaline phosphatase (BAP), and tartrate-resistant acid phosphatase (TRAcP) 5b(The 6th month)
- Blood concentrations of high-sensitive C reactive protein (CRP), interleukin (IL)-6, and tumor necrosis factor (TNF)-alpha(The 6th month)
研究者
Takayuki Hamano
Associate Professor
Osaka University