Selenium and Ischemic Stroke Outcome

NCT02505295 | Completed DMC

• 1 other identifier: 1421
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• 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.

  up to 3 days

• 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.

  at day 5-8

Secondary Outcomes (1)

• Barthel index

  3 months after discharge

Study Arms (2)

selenium

ACTIVE COMPARATOR

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

Dietary Supplement: Selenium

normal saline

PLACEBO COMPARATOR

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

Drug: normal saline

Interventions

Selenium DIETARY_SUPPLEMENT

4 vials selenase stat and 2 vials daily for 5 days

Also known as: selenase, Selenium selenite

selenium

normal saline DRUG

Normal saline infusion like intervention group

Also known as: Sodium chloride 0.9%

normal saline

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mazandaran University of Medical Sciences: lead

Study Sites (1)

Athena Sharifi Razavi

Sari, Mazandaran, 4818777111, Iran

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Selenium; selenium-cisplatin conjugate; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Minerals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Study Officials

• athena sharifi razavi, MD

  assistant professor in neurology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: This study is a feasibility/pilot study

Study Record Dates

• First Submitted: July 11, 2015
• First Posted: July 22, 2015
• Study Start: October 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

IR (1)