Efficacy of High Dose Vitamin C Parenteral Supplement on Amelioration of Fatigue in Company Workers After Work: A Double-Blind, Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Degree of fatigue at the point of time with visual analogue scale from 0 to 10
研究概览
简要总结
Fatigue is one of the most frequently observed symptoms for company workers, and oxidative stress is regarded as one of its cause. Vitamin C is a well-known antioxidant, and the investigators seek for evidence of the efficacy of high dose vitamin C parenteral supplement on fatigue symptoms of company workers after work.
详细描述
Previous studies dealing with vitamin C were focusing on terminal cancer patients or those with chronic fatigue syndrome. Since used drug dosage and the ways of administering vitamin C were not identical, the results were not consistent throughout those studies. This study is aimed to evaluate the efficacy of high dose vitamin C with parenteral supplement on relieving fatigue for apparently healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Company workers working at least 5 days a week from morning to evening
- •Volunteers who provided written informed consent
排除标准
- •Acute illness
- •Chronic disease such as diabetes, hypertension, liver disease, or renal disease
- •Previous history of renal stone or gout
- •Pregnant or lactating women
- •Hypersensitivity to vitamins or intravenous injections
- •History of vitamin supplements orally or parenterally within 2 days
研究组 & 干预措施
1
Intravenous injections of 10 grams(20ml as a solution) of vitamin C with 100ml of normal saline over 30 minutes.
干预措施: Ascorbic acid (Vitamin C) (Dietary Supplement)
2
Intravenous injections of 120ml of normal saline over 30 minutes.
干预措施: Normal saline (Dietary Supplement)
结局指标
主要结局
Degree of fatigue at the point of time with visual analogue scale from 0 to 10
时间窗: Before intravenous vitamin C injection and right after completing injections, and one day later
次要结局
- Reactive oxygen species(Before intravenous vitamin C injections, right after completing injections, and one day later)
- Plasma vitamin C level(Before intravenous vitamin C injections and right after completing injections)