Selenium and Ischemic Stroke Outcome

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Selenium Supplementation in Ischemic Stroke Outcome

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Dietary Supplement: Selenium
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is a feasibility/pilot study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: selenium<br>vial selenium (selenase 500 microgr ) 2000 microgram stat and 1000 microgram daily for 5 days | Dietary Supplement: Selenium<br>* 4 vials selenase stat and 2 vials daily for 5 days<br>* Other names: Selenium selenite;|
| Placebo Comparator: normal saline<br>40 cc normal saline stat and 20 cc daily for 5 days( in vials like selenase vial) | Drug: normal saline<br>* Normal saline infusion like intervention group<br>* Other names: Sodium chloride 0.9%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Institutes of Health Stroke Scale(NIHSS) | 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. | up to 3 days | 
| modified Rankin Scale (MRS) | 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. | at day 5-8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel index | The secondary outcome defined as Barthel index >75 three months after stroke, which indicates assisted independence, for long term outcome evaluation and comparison of mortality rate during the study follow-up between groups. | 3 months after discharge |