Selenium and Ischemic Stroke Outcome

Mazandaran University of Medical Sciences44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Ischemic Stroke

Interventions

SeleniumDIETARY_SUPPLEMENT

4 vials selenase stat and 2 vials daily for 5 days

normal salineDRUG

Normal saline infusion like intervention group

Eligibility

Sex: ALLMin age: 20 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Accepted ischemic stroke by brain CT or MRI during last 72 h 2. Ischemic stroke in Middle Cerebral Artery territory 3. Volume of stroke at list one third of MCA territory 4. written informed consent. Exclusion Criteria: 1. Known allergy to selenium 2. Severe renal failure( cr clearance under 50 ml/min or serum cr upper than 2 3. Severe hepatic failure( total bill upper than 2 or ALT/AST 5 time upper than normal limit) 4. Severe neurodegenerative disease such as severe dementia, alzheimer and Parkinson 5. Pregnancy or lactation

Locations (1)

Athena Sharifi Razavi

Sari, Mazandaran, Iran

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: at day 5-8

Secondary Outcomes

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.

Time frame: 3 months after discharge

Data from ClinicalTrials.gov

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