Evaluation of Selenium Supplementation in Ischemic Stroke Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- modified Rankin Scale (MRS)
研究概览
简要总结
Selenium is a trace element essential to human health.Selenium protection against cellular damage by oxygen radicals is accomplished through selenoproteins. Ischemic stroke is associated with the generation of oxygen free radicals resulting in a condition of oxidative stress. Supplementing stroke patients with antioxidant nutrients may improve survival.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Accepted ischemic stroke by brain CT or MRI during last 72 h
- •Ischemic stroke in Middle Cerebral Artery territory
- •Volume of stroke at list one third of MCA territory
- •written informed consent.
排除标准
- •Known allergy to selenium
- •Severe renal failure( cr clearance under 50 ml/min or serum cr upper than 2
- •Severe hepatic failure( total bill upper than 2 or ALT/AST 5 time upper than normal limit)
- •Severe neurodegenerative disease such as severe dementia, alzheimer and Parkinson
- •Pregnancy or lactation
研究组 & 干预措施
selenium
vial selenium (selenase 500 microgr ) 2000 microgram stat and 1000 microgram daily for 5 days
干预措施: Selenium (Dietary Supplement)
normal saline
40 cc normal saline stat and 20 cc daily for 5 days( in vials like selenase vial)
干预措施: normal saline (Drug)
结局指标
主要结局
modified Rankin Scale (MRS)
时间窗: at day 5-8
The primary outcome of interest in this study was defined as at least 1 point reduction in mRS score in day 7 or at the discharge in selenium group compared with control; as an indicator of short term outcome.
National Institutes of Health Stroke Scale(NIHSS)
时间窗: up to 3 days
The primary outcome of interest in this study was defined as at least 25% reduction in NIHSS score in day 7 or at the discharge in selenium group compared with control; as an indicator of short term outcome.
次要结局
- Barthel index(3 months after discharge)
研究者
Athena Sharifi Razavi
Assistant professor
Mazandaran University of Medical Sciences