Selenium and Ischemic Stroke Outcome

January 22, 2020 updated by: Athena Sharifi Razavi, Mazandaran University of Medical Sciences

Evaluation of Selenium Supplementation in 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 3 days
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.
at day 5-8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mazandaran University of Medical Sciences

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

July 11, 2015

First Submitted That Met QC Criteria

July 21, 2015

First Posted (Estimate)

July 22, 2015

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 22, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1421

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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