Back to resultsSelenium and Ischemic Stroke Outcome
Primary Purpose
Ischemic Stroke
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Selenium
normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke
Eligibility Criteria
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
Sites / Locations
- Athena Sharifi Razavi
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
selenium
normal saline
Arm Description
vial selenium (selenase 500 microgr ) 2000 microgram stat and 1000 microgram daily for 5 days
40 cc normal saline stat and 20 cc daily for 5 days( in vials like selenase vial)
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02505295
First Posted
July 11, 2015
Last Updated
January 22, 2020
Sponsor
Mazandaran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02505295
Brief Title
Selenium and Ischemic Stroke Outcome
Official Title
Evaluation of Selenium Supplementation in Ischemic Stroke Outcome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mazandaran University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is a feasibility/pilot study
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
selenium
Arm Type
Active Comparator
Arm Description
vial selenium (selenase 500 microgr ) 2000 microgram stat and 1000 microgram daily for 5 days
Arm Title
normal saline
Arm Type
Placebo Comparator
Arm Description
40 cc normal saline stat and 20 cc daily for 5 days( in vials like selenase vial)
Intervention Type
Dietary Supplement
Intervention Name(s)
Selenium
Other Intervention Name(s)
selenase, Selenium selenite
Intervention Description
4 vials selenase stat and 2 vials daily for 5 days
Intervention Type
Drug
Intervention Name(s)
normal saline
Other Intervention Name(s)
Sodium chloride 0.9%
Intervention Description
Normal saline infusion like intervention group
Primary Outcome Measure Information:
Title
National Institutes of Health Stroke Scale(NIHSS)
Description
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
Title
modified Rankin Scale (MRS)
Description
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 Outcome Measure Information:
Title
Barthel index
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
athena sharifi razavi, MD
Organizational Affiliation
assistant professor in neurology
Official's Role
Study Chair
Facility Information:
Facility Name
Athena Sharifi Razavi
City
Sari
State/Province
Mazandaran
ZIP/Postal Code
4818777111
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Selenium and Ischemic Stroke Outcome
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