Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-02-22 @ 10:36 PM
Study NCT ID:
NCT00613392
Status:
TERMINATED
Last Update Posted:
2016-01-26
First Post:
2008-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antioxidant Supplementation in Trauma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009104', 'term': 'Multiple Trauma'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'whyStopped': 'Supplement expired and unable to obtain more from company manufacturing', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-25', 'studyFirstSubmitDate': '2008-01-30', 'studyFirstSubmitQcDate': '2008-02-11', 'lastUpdatePostDateStruct': {'date': '2016-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measures of malondialdehyde level/total antioxidant status and F2 isoprostane', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['antioxidant', 'oxidant stress', 'trauma', 'free radical'], 'conditions': ['Multiple Trauma']}, 'descriptionModule': {'briefSummary': 'Administration of antioxidants to trauma patients will improve measures of oxidant stress in the blood'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult non pregnant non lactating trauma patient\n\nExclusion Criteria:\n\n* GCS \\<6\n* Renal dysfunction (cre \\> 2.5 mg/dl)\n* Hepatic dysfunction ( TBili \\> 3.0 mg/dl)\n* Expected survival \\< 48 hours\n* Burns over \\> 20% body surface area\n* Immune-deficiency syndromes\n* Steroid use'}, 'identificationModule': {'nctId': 'NCT00613392', 'briefTitle': 'Antioxidant Supplementation in Trauma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Boston Medical Center'}, 'officialTitle': 'Antioxidant Supplementation in Trauma Patients', 'orgStudyIdInfo': {'id': 'H-25038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Dietary Supplement: powdered antioxidant']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Dietary Supplement: powdered cornstarch placebo']}], 'interventions': [{'name': 'powdered antioxidant', 'type': 'DIETARY_SUPPLEMENT', 'description': 'one vial mixed with water every day orally or through enteral tube', 'armGroupLabels': ['1']}, {'name': 'powdered cornstarch placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'one vial mix with water and administer orally or via enteral tube', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Peter Burke, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Boston Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}