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OpenTrials
Completed

NCT Number: NCT02505295

Selenium and Ischemic Stroke Outcome

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Athena Sharifi Razavi

Sari, Mazandaran, 4818777111, Iran

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Selenium

Dietary Supplement

4 vials selenase stat and 2 vials daily for 5 days

Other names: selenase, Selenium selenite

normal saline

Drug

Normal saline infusion like intervention group

Other names: Sodium chloride 0.9%

Primary outcomes

  1. National Institutes of Health Stroke Scale(NIHSS)

    Time frame: 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.

  2. modified Rankin Scale (MRS)

    Time frame: 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.

Secondary outcomes

  1. Barthel index

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mazandaran University of Medical Sciences

Other

Registry information

Official study title

Evaluation of Selenium Supplementation in Ischemic Stroke Outcome

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 22, 2015
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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