Ischemic StrokeNCT02505295
Selenium and Ischemic Stroke Outcome
A study testing Selenium and normal saline in people with Ischemic Stroke, run by Mazandaran University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Selenium and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteIran
- Study dates
- Oct 2015to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Ischemic Stroke
- Being tested
- Selenium, normal saline
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeleniumDietary supplement
Also called selenase, Selenium selenite
4 vials selenase stat and 2 vials daily for 5 days
normal salineDrug
Also called Sodium chloride 0.9%
Normal saline infusion like intervention group
| Study group | Role | What they receive |
|---|---|---|
| selenium | Active comparator | vial selenium (selenase 500 microgr ) 2000 microgram stat and 1000 microgram daily for 5 days Receives: Dietary Supplement: Selenium |
| normal saline | Placebo comparator | 40 cc normal saline stat and 20 cc daily for 5 days( in vials like selenase vial) Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: at day 5-8
Secondary outcomes (1)
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.
Measured: 3 months after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startOct 2015
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a feasibility/pilot study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mazandaran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Athena Sharifi Razavi, Mazandaran University of Medical Sciences
- Investigators
- athena sharifi razavi, MD, Study chair, assistant professor in neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505295
- Sponsor's protocol ID
- 1421
- Status last verified
- Jan 2020
- First submitted
- 11 Jul 2015
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Selenium Supplementation in Ischemic Stroke Outcome
- ClinicalTrials.gov ID
- NCT02505295
- Acronym / sponsor ID
- 1421
- Conditions
- Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Mazandaran University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a feasibility/pilot study
| Arm | Type | Receives |
|---|---|---|
| selenium | Active comparator | Dietary Supplement: Seleniumvial selenium (selenase 500 microgr ) 2000 microgram stat and 1000 microgram daily for 5 days |
| normal saline | Placebo comparator | Drug: normal saline40 cc normal saline stat and 20 cc daily for 5 days( in vials like selenase vial) |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeleniumAlso: selenase, Selenium selenite4 vials selenase stat and 2 vials daily for 5 days | Dietary supplement | selenium |
| normal salineAlso: Sodium chloride 0.9%Normal saline infusion like intervention group | Drug | normal saline |
Primary outcome
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.
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.
1 secondary outcome
Barthel index
Time frame: 3 months after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
athena sharifi razavi, MD study chair
assistant professor in neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selenium and normal saline in people with Ischemic Stroke, run by Mazandaran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National Institutes of Health Stroke Scale(NIHSS) (time frame: up to 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.