Effects of Multiple Mega-dose of Vitamin D3 Supplementation on Ameliorating Moderate to Severe Chronic Pain in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale of Pain
研究概览
简要总结
Pain is a major complaint in hemodialysis (HD) patients. Concentrations of parathyroid hormone (PTH) >250 pg/ml are associated with chronic pain. Visual Analogue Scale (VAS) score which is used to assess the pain severity is positively related to PTH levels. This study is aimed to assess the effects of multiple mega dosages vitamin D supplementations in HD patients with chronic pain. It's a single-center, parallel, double-blind randomized control trial that administrations of 576,000 IU once a week of vitamin D3 for 4 weeks or placebo are for 120 eligible subjects. VAS and laboratory tests including serum concentrations of 25(OH)D, calcium, phosphorus, PTH and C-reactive protein will be evaluated.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Haemodialysis subject ≥ 20 years old
- •iPTH > 250 pg/mL
- •Chronic pain with visual analogue scale (VAS) score ≥ 4
- •Voluntary to check serum 25(OH)D levels two times by his/her own payment during the study
- •Sign the informed consent
排除标准
- •Used to participate in other clinical trials
- •Chronic liver disease
- •Sarcoidosis or multiple myeloma
结局指标
主要结局
Visual Analogue Scale of Pain
时间窗: week 5 (day 29)
次要结局
- Serum phosphorus(Baseline (day 1) and week 5 (day 29) post-supplementation)
- Concentrations of parathyroid hormone (PTH)(Baseline (day 1) and week 5 (day 29) post-supplementation)
- 25(OH)D level(Baseline (day 1) and week 5 (day 29) post-supplementation)
- Serum calcium(Baseline (day 1) and week 5 (day 29) post-supplementation)
- C-reactive protein (CRP) test(Baseline (day 1) and week 5 (day 29) post-supplementation)