Selenium and Ischemic Stroke Outcome

Evaluation of Selenium Supplementation in Ischemic Stroke Outcome

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02505295

Enrollment

Registered

2015-07-22

Start date

2015-10-31

Completion date

2018-01-31

Last updated

2020-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

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.

Interventions

DIETARY_SUPPLEMENTSelenium

4 vials selenase stat and 2 vials daily for 5 days

DRUGnormal saline

Normal saline infusion like intervention group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Intervention model description

This study is a feasibility/pilot study

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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

Measure	Time frame	Description
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.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026