Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2026-02-25 @ 8:27 PM
Study NCT ID:
NCT02505295
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2015-07-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Selenium and Ischemic Stroke Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012643', 'term': 'Selenium'}, {'id': 'C110743', 'term': 'selenium-cisplatin conjugate'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008903', 'term': 'Minerals'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a feasibility/pilot study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-22', 'studyFirstSubmitDate': '2015-07-11', 'studyFirstSubmitQcDate': '2015-07-21', 'lastUpdatePostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'National Institutes of Health Stroke Scale(NIHSS)', 'timeFrame': 'up to 3 days', 'description': '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.'}, {'measure': 'modified Rankin Scale (MRS)', 'timeFrame': 'at day 5-8', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Barthel index', 'timeFrame': '3 months after discharge', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ischemic Stroke']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Accepted ischemic stroke by brain CT or MRI during last 72 h\n2. Ischemic stroke in Middle Cerebral Artery territory\n3. Volume of stroke at list one third of MCA territory\n4. written informed consent.\n\nExclusion Criteria:\n\n1. Known allergy to selenium\n2. Severe renal failure( cr clearance under 50 ml/min or serum cr upper than 2\n3. Severe hepatic failure( total bill upper than 2 or ALT/AST 5 time upper than normal limit)\n4. Severe neurodegenerative disease such as severe dementia, alzheimer and Parkinson\n5. Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT02505295', 'briefTitle': 'Selenium and Ischemic Stroke Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Mazandaran University of Medical Sciences'}, 'officialTitle': 'Evaluation of Selenium Supplementation in Ischemic Stroke Outcome', 'orgStudyIdInfo': {'id': '1421'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'selenium', 'description': 'vial selenium (selenase 500 microgr ) 2000 microgram stat and 1000 microgram daily for 5 days', 'interventionNames': ['Dietary Supplement: Selenium']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'normal saline', 'description': '40 cc normal saline stat and 20 cc daily for 5 days( in vials like selenase vial)', 'interventionNames': ['Drug: normal saline']}], 'interventions': [{'name': 'Selenium', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['selenase', 'Selenium selenite'], 'description': '4 vials selenase stat and 2 vials daily for 5 days', 'armGroupLabels': ['selenium']}, {'name': 'normal saline', 'type': 'DRUG', 'otherNames': ['Sodium chloride 0.9%'], 'description': 'Normal saline infusion like intervention group', 'armGroupLabels': ['normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4818777111', 'city': 'Sari', 'state': 'Mazandaran', 'country': 'Iran', 'facility': 'Athena Sharifi Razavi', 'geoPoint': {'lat': 36.56332, 'lon': 53.06009}}], 'overallOfficials': [{'name': 'athena sharifi razavi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'assistant professor in neurology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mazandaran University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Athena Sharifi Razavi', 'investigatorAffiliation': 'Mazandaran University of Medical Sciences'}}}}