Selenium and Ischemic Stroke Outcome

Ischemic Stroke Clinical Trial

Official title:

Evaluation of Selenium Supplementation in Ischemic Stroke Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02505295
• Other study ID #: 1421
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: January 2018

Study information

• Verified date: January 2020
• Source: Mazandaran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Dietary Supplement:
• Selenium
4 vials selenase stat and 2 vials daily for 5 days

Drug:
• normal saline
Normal saline infusion like intervention group

Locations

Country	Name	City	State
Iran, Islamic Republic of	Athena Sharifi Razavi	Sari	Mazandaran

Sponsors (1)

Lead Sponsor	Collaborator
Mazandaran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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