Efficacy of Vitamin C, Vitamin E and Their Combination for Treatment of Restless Legs Syndrome in Hemodialysis Patients: a Randomized Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Absolute Change in IRLS Sum Score
研究概览
简要总结
The purpose of this study is to determine whether vitamin C, vitamin E and their combination are effective in the treatment of RLS in hemodialysis patients.
详细描述
RLS is a common problem in hemodialysis patients; 20 to 40% of hemodialysis patients suffer from RLS. Hemodialysis patients have a high oxidative stress status. Oxidative stress has been proposed to play an important role in the pathogenesis of RLS. Vitamin C and vitamin E are potent antioxidant agents that have already been shown to be effective in the treatment of periodic limb movement disorder (PLMD) in hemodialysis patients. PLMD is closely associated with RLS in hemodialysis patients. The aim of this study was to evaluate the efficacy of vitamin C, vitamin E and their combination in the treatment of RLS in hemodialysis patients.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who fulfill Restless leg syndrome international criteria(IRLSSG)
- •Patients who are stable on HD without any internment illness or admission
排除标准
- •Patients who have renal stone
- •Patients who receive medications with RLS aggravating or alleviating properties
研究组 & 干预措施
Vitamin C & Vitamin E.
The patients in this arm received one tablet of vitamin C (200 mg) and one capsule of vitamin E (400 mg) daily for 8 weeks
干预措施: Vitamin C & Vitamin E (Drug)
Vitamin C & Placebo
The patients in this arm received one tablet of vitamin C (200 mg) and one placebo capsule daily for 8 weeks.
干预措施: Vitamin C (Drug)
Vitamin E & Placebo
The patients in this arm received one capsule of vitamin E (400 mg) and one placebo tablet daily for 8 weeks.
干预措施: Vitamin E (Drug)
Double Placebo
The patients in this arm received one placebo capsule and one placebo tablet daily for 8 weeks.
干预措施: Vitamin C Placebo & Vitamin E Placebo (Drug)
结局指标
主要结局
Absolute Change in IRLS Sum Score
时间窗: 8 Weeks
Absolute Change in IRLS Sum Score from Baseline to the End of Treatment Phase in Intention-to-treat Population
次要结局
- Number of participants with adverse events(8 Weeks)