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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| selenium | Active Comparator | vial selenium (selenase 500 microgr ) 2000 microgram stat and 1000 microgram daily for 5 days |
|
| normal saline | Placebo Comparator | 40 cc normal saline stat and 20 cc daily for 5 days( in vials like selenase vial) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selenium | Dietary Supplement | 4 vials selenase stat and 2 vials daily for 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months after discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| athena sharifi razavi, MD | assistant professor in neurology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Athena Sharifi Razavi | Sari | Mazandaran | 4818777111 | Iran |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D012643 | Selenium |
| C110743 | selenium-cisplatin conjugate |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008903 | Minerals |
| D000077324 |
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This study is a feasibility/pilot study
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| normal saline | Drug | Normal saline infusion like intervention group |
|
|
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D017670 | Sodium Compounds |