Selenium and Ischemic Stroke Outcome

Not Applicable

Completed

• Conditions: Ischemic Stroke
• Interventions: Drug: normal saline; Dietary Supplement: Selenium

• Registration Number: NCT02505295
• Lead Sponsor: Mazandaran University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-11
• Study First Submitted QC: 2015-07-21
• Study First Posted: 2015-07-22
• Study Start: 2015-10
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal saline	normal saline	40 cc normal saline stat and 20 cc daily for 5 days( in vials like selenase vial)
selenium	Selenium	vial selenium (selenase 500 microgr ) 2000 microgram stat and 1000 microgram daily for 5 days

Primary Outcome Measures

Name	Time	Method
modified Rankin Scale (MRS)	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)	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.

Secondary Outcome Measures

Name	Time	Method
Barthel index	3 months after discharge	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.

Trial Locations

Locations (1)

Athena Sharifi Razavi; 🇮🇷 Sari, Mazandaran, Iran, Islamic Republic of