Selenium and Ischemic Stroke Outcome

NCT ID: NCT02505295

Last Updated: 2020-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-01-31

Brief Summary

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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

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Conditions

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Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a feasibility/pilot study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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selenium

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

Group Type ACTIVE_COMPARATOR

Selenium

Intervention Type DIETARY_SUPPLEMENT

4 vials selenase stat and 2 vials daily for 5 days

normal saline

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

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

Normal saline infusion like intervention group

Interventions

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Selenium

4 vials selenase stat and 2 vials daily for 5 days

Intervention Type DIETARY_SUPPLEMENT

normal saline

Normal saline infusion like intervention group

Intervention Type DRUG

Other Intervention Names

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selenase Selenium selenite Sodium chloride 0.9%

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mazandaran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Athena Sharifi Razavi

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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athena sharifi razavi, MD

Role: STUDY_CHAIR

assistant professor in neurology

Locations

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Athena Sharifi Razavi

Sari, Mazandaran, Iran

Site Status

Countries

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Iran

Other Identifiers

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1421

Identifier Type: -

Identifier Source: org_study_id

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