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Selenium and Ischemic Stroke Outcome

Sponsor
Mazandaran University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT02505295
Collaborator
(none)
44
Enrollment
1
Location
2
Arms
27
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Selenium
  • Drug: normal saline
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This study is a feasibility/pilot studyThis study is a feasibility/pilot study
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluation of Selenium Supplementation in Ischemic Stroke Outcome
Actual Study Start Date :
Oct 1, 2015
Actual Primary Completion Date :
Jan 1, 2018
Actual Study Completion Date :
Jan 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: selenium

vial selenium (selenase 500 microgr ) 2000 microgram stat and 1000 microgram daily for 5 days

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

    		•
    Placebo Comparator: normal saline

    40 cc normal saline stat and 20 cc daily for 5 days( in vials like selenase vial)

    Drug: normal saline
    Normal saline infusion like intervention group
    Other Names:
  • Sodium chloride 0.9%

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    Secondary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Athena Sharifi Razavi Sari Mazandaran Iran, Islamic Republic of 4818777111

    Sponsors and Collaborators

    • Mazandaran University of Medical Sciences

    Investigators

    • Study Chair: athena sharifi razavi, MD, assistant professor in neurology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Athena Sharifi Razavi, Assistant professor, Mazandaran University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT02505295
    Other Study ID Numbers:
    • 1421
    First Posted:
    Jul 22, 2015
    Last Update Posted:
    Jan 27, 2020
    Last Verified:
    Jan 1, 2020
    Additional relevant MeSH terms:
    Stroke
    Ischemic Stroke
    Cerebral Infarction
    Ischemia
    Selenium

    Study Results

    No Results Posted as of Jan 27, 2020