Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-01-11 @ 4:12 PM
Study NCT ID:
NCT03345550
Status:
TERMINATED
Last Update Posted:
2023-05-23
First Post:
2017-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
OPTIMA-TBI Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001924', 'term': 'Brain Concussion'}], 'ancestors': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D016489', 'term': 'Head Injuries, Closed'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014949', 'term': 'Wounds, Nonpenetrating'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004281', 'term': 'Docosahexaenoic Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}], 'ancestors': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'korley@med.umich.edu', 'phone': '734 647-0261', 'title': 'Frederick Korley', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Omega-3 Polyunsaturated Fatty Acid Treatment Arm', 'description': 'Participants randomized to this study arm received 6g DHA+EPA for one month followed by 1.2 g DHA+EPA for two months. Capsules contain fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules.\n\nOmega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA)) or placebo capsules.: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 3, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Arm', 'description': 'Participants randomized to this study arm received placebo drug for 3 months.\n\nPlacebo - Cap: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules (olive oil capsules that look identical to the intervention DHA+EPA).', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Biomarker Endpoints (NFL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omega-3 Polyunsaturated Fatty Acid Treatment Arm', 'description': 'Participants randomized to this study arm received 6g DHA+EPA for one month followed by 1.2 g DHA+EPA for two months. Capsules contain fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules.\n\nOmega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA)) or placebo capsules.: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules.'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Participants randomized to this study arm received placebo drug for 3 months.\n\nPlacebo - Cap: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules (olive oil capsules that look identical to the intervention DHA+EPA).'}], 'classes': [{'title': 'NFL baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '11.4'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '4.4', 'upperLimit': '10.0'}]}]}, {'title': 'NFL 1 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '3.9', 'upperLimit': '12.7'}, {'value': '8.7', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '13.4'}]}]}, {'title': 'NFL 3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '9.5'}, {'value': '9.7', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '20.0'}]}]}], 'analyses': [{'pValue': '.24', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Baseline', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.43', 'groupIds': ['OG000', 'OG001'], 'groupDescription': '1 month analysis', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '.54', 'groupIds': ['OG000', 'OG001'], 'groupDescription': '3 month', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline,3 months', 'description': 'Neuronal injury measured by Neurofilament Light Chain (NFL). Samples will be analyzed using a digital immunoassay based on a single molecule counting technology.', 'unitOfMeasure': 'picograms per ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "For some of the assays, some individuals' data was not available."}, {'type': 'PRIMARY', 'title': 'Biomarker Endpoint (Inflammation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omega-3 Polyunsaturated Fatty Acid Treatment Arm', 'description': 'Participants randomized to this study arm received 6g DHA+EPA for one month followed by 1.2 g DHA+EPA for two months. Capsules contain fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules.\n\nOmega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA)) or placebo capsules.: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules.'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Participants randomized to this study arm received placebo drug for 3 months.\n\nPlacebo - Cap: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules (olive oil capsules that look identical to the intervention DHA+EPA).'}], 'timeFrame': '3 months', 'description': 'We will measure serum levels of high sensitivity C-Reactive Protein (CRP)', 'reportingStatus': 'POSTED', 'populationDescription': 'While serum was collected no CRP data or measurements were made or can be made now or in the future.'}, {'type': 'PRIMARY', 'title': 'Biomarker Endpoint (Neurogenesis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omega-3 Polyunsaturated Fatty Acid Treatment Arm', 'description': 'Participants randomized to this study arm received 6g DHA+EPA for one month followed by 1.2 g DHA+EPA for two months. Capsules contain fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules.\n\nOmega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA)) or placebo capsules.: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules.'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Participants randomized to this study arm received placebo drug for 3 months.\n\nPlacebo - Cap: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules (olive oil capsules that look identical to the intervention DHA+EPA).'}], 'timeFrame': '3 months', 'description': 'Serum levels of brain derived neurotrophic factor (BDNF)', 'reportingStatus': 'POSTED', 'populationDescription': 'While serum was collected, no BDNF data or measurements were collected or can be made now or in the future.'}, {'type': 'SECONDARY', 'title': 'Delayed Functional Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omega-3 Polyunsaturated Fatty Acid Treatment Arm', 'description': 'Participants randomized to this study arm received 6g DHA+EPA for one month followed by 1.2 g DHA+EPA for two months. Capsules contain fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules.\n\nOmega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA)) or placebo capsules.: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules.'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Participants randomized to this study arm received placebo drug for 3 months.\n\nPlacebo - Cap: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules (olive oil capsules that look identical to the intervention DHA+EPA).'}], 'classes': [{'categories': [{'title': 'Upper good recovery at 3 months (GOSE=8)', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Lower good recovery at 3 months (GOSE=7)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.31', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'Delayed functional recovery will be defined as a Glasgow Outcome Scale Extended (GOSE) \\<8 at 3 months. Scores range from 1-8. 8 is Upper good recovery and 1 is death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Gastrointestinal Distress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omega-3 Polyunsaturated Fatty Acid Treatment Arm', 'description': 'Participants randomized to this study arm received 6g DHA+EPA for one month followed by 1.2 g DHA+EPA for two months. Capsules contain fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules.\n\nOmega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA)) or placebo capsules.: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules.'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Participants randomized to this study arm received placebo drug for 3 months.\n\nPlacebo - Cap: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules (olive oil capsules that look identical to the intervention DHA+EPA).'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'GI distress is measured by number of individuals who experienced it.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinically Significant Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omega-3 Polyunsaturated Fatty Acid Treatment Arm', 'description': 'Participants randomized to this study arm received 6g DHA+EPA for one month followed by 1.2 g DHA+EPA for two months. Capsules contain fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules.\n\nOmega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA)) or placebo capsules.: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules.'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Participants randomized to this study arm received placebo drug for 3 months.\n\nPlacebo - Cap: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules (olive oil capsules that look identical to the intervention DHA+EPA).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'Clinically significant bleeding distress is measured by number of individuals who experienced it.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All 22 participants were analyzed on an Intention to Treat analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cognitive Impairment', 'timeFrame': '3 months', 'description': "Cognitive impairment will be defined by a battery of neurocognitive tests including the Montreal Cognitive Assessment (MOCA), Hopkins Verbal Learning Test (HVLT), Trails A and B, Brief Visuospatial Memory Test (BVMT), Stroop Test, Wechsler Test of Adult Reading (WTAR), Brief Test of Attention, (BTA), Wisconsin Card Sorting Test (WCST) and COWAT (Controlled Oral Word Association Test). The WTAR will be used as an estimate of IQ and the neurocognitive test T-scores of interest will be compared against the subject's IQ T-score. The standard deviation (SD) of each T-score is 10. Each of the subject's neurocognitive tests is considered aberrant if it is more than 2 SD below the subject's IQ T-score. A subject is considered cognitively impaired if at least 2 (based on the .05 rule; 5 out of every 100 test scores will be outside of expected range by chance alone) out of the T-scores are aberrant.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Moderate/Severe Post-Concussive Symptoms', 'timeFrame': '3 months', 'description': 'Moderate/severe post-concussive symptoms will be defined as the presence of any one or more of the following: headaches, dizziness, general malaise, excessive fatigue, or noise intolerance, irritability, emotional lability, depression, or anxiety, subjective complaints of concentration or memory difficulty, insomnia, reduced tolerance to alcohol, preoccupation with these symptoms and fear of permanent brain damage. These will be self-reported by the patient.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'POST_HOC', 'title': 'Glial Fibrillary Acidic Protein (GFAP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omega-3 Polyunsaturated Fatty Acid Treatment Arm', 'description': 'Participants randomized to this study arm received 6g DHA+EPA for one month followed by 1.2 g DHA+EPA for two months. Capsules contain fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules.\n\nOmega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA)) or placebo capsules.: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules.'}, {'id': 'OG001', 'title': 'Placebo Arm', 'description': 'Participants randomized to this study arm received placebo drug for 3 months.\n\nPlacebo - Cap: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules (olive oil capsules that look identical to the intervention DHA+EPA).'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.9', 'groupId': 'OG000', 'lowerLimit': '56.8', 'upperLimit': '158.0'}, {'value': '53.7', 'groupId': 'OG001', 'lowerLimit': '40.4', 'upperLimit': '123.0'}]}]}, {'title': '1 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.0', 'groupId': 'OG000', 'lowerLimit': '41.3', 'upperLimit': '91.0'}, {'value': '87.7', 'groupId': 'OG001', 'lowerLimit': '59.6', 'upperLimit': '118.8'}]}]}, {'title': '3 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.2', 'groupId': 'OG000', 'lowerLimit': '31.2', 'upperLimit': '99.7'}, {'value': '68.4', 'groupId': 'OG001', 'lowerLimit': '45.7', 'upperLimit': '129.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'unitOfMeasure': 'picograms per ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing blood samples due to loss of follow-up.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Omega-3 Polyunsaturated Fatty Acid Treatment Arm', 'description': 'Participants randomized to this study arm received 6g DHA+EPA for one month followed by 1.2 g DHA+EPA for two months. Capsules contain fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules.\n\nOmega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA)) or placebo capsules.: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules.'}, {'id': 'FG001', 'title': 'Placebo Arm', 'description': 'Participants randomized to this study arm received placebo drug for 3 months.\n\nPlacebo - Cap: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules (olive oil capsules that look identical to the intervention DHA+EPA).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'First Received Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Omega-3 Polyunsaturated Fatty Acid Treatment Arm', 'description': 'Participants randomized to this study arm received 6g DHA+EPA for one month followed by 1.2 g DHA+EPA for two months. Capsules contain fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules.\n\nOmega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA)) or placebo capsules.: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules.'}, {'id': 'BG001', 'title': 'Placebo Arm', 'description': 'Participants randomized to this study arm received placebo drug for 3 months.\n\nPlacebo - Cap: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules (olive oil capsules that look identical to the intervention DHA+EPA).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.5', 'groupId': 'BG000', 'lowerLimit': '24.8', 'upperLimit': '46.5'}, {'value': '26.5', 'groupId': 'BG001', 'lowerLimit': '22.8', 'upperLimit': '38.5'}, {'value': '30.5', 'groupId': 'BG002', 'lowerLimit': '23.2', 'upperLimit': '43.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-08', 'size': 420440, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-07-26T12:55', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'whyStopped': 'Slow accrual of patients, lack of financial resources', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-27', 'studyFirstSubmitDate': '2017-11-12', 'resultsFirstSubmitDate': '2022-07-26', 'studyFirstSubmitQcDate': '2017-11-15', 'lastUpdatePostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-27', 'studyFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cognitive Impairment', 'timeFrame': '3 months', 'description': "Cognitive impairment will be defined by a battery of neurocognitive tests including the Montreal Cognitive Assessment (MOCA), Hopkins Verbal Learning Test (HVLT), Trails A and B, Brief Visuospatial Memory Test (BVMT), Stroop Test, Wechsler Test of Adult Reading (WTAR), Brief Test of Attention, (BTA), Wisconsin Card Sorting Test (WCST) and COWAT (Controlled Oral Word Association Test). The WTAR will be used as an estimate of IQ and the neurocognitive test T-scores of interest will be compared against the subject's IQ T-score. The standard deviation (SD) of each T-score is 10. Each of the subject's neurocognitive tests is considered aberrant if it is more than 2 SD below the subject's IQ T-score. A subject is considered cognitively impaired if at least 2 (based on the .05 rule; 5 out of every 100 test scores will be outside of expected range by chance alone) out of the T-scores are aberrant."}, {'measure': 'Moderate/Severe Post-Concussive Symptoms', 'timeFrame': '3 months', 'description': 'Moderate/severe post-concussive symptoms will be defined as the presence of any one or more of the following: headaches, dizziness, general malaise, excessive fatigue, or noise intolerance, irritability, emotional lability, depression, or anxiety, subjective complaints of concentration or memory difficulty, insomnia, reduced tolerance to alcohol, preoccupation with these symptoms and fear of permanent brain damage. These will be self-reported by the patient.'}], 'primaryOutcomes': [{'measure': 'Biomarker Endpoints (NFL)', 'timeFrame': 'Baseline,3 months', 'description': 'Neuronal injury measured by Neurofilament Light Chain (NFL). Samples will be analyzed using a digital immunoassay based on a single molecule counting technology.'}, {'measure': 'Biomarker Endpoint (Inflammation)', 'timeFrame': '3 months', 'description': 'We will measure serum levels of high sensitivity C-Reactive Protein (CRP)'}, {'measure': 'Biomarker Endpoint (Neurogenesis)', 'timeFrame': '3 months', 'description': 'Serum levels of brain derived neurotrophic factor (BDNF)'}], 'secondaryOutcomes': [{'measure': 'Delayed Functional Recovery', 'timeFrame': '3 months', 'description': 'Delayed functional recovery will be defined as a Glasgow Outcome Scale Extended (GOSE) \\<8 at 3 months. Scores range from 1-8. 8 is Upper good recovery and 1 is death'}, {'measure': 'Gastrointestinal Distress', 'timeFrame': '3 months', 'description': 'GI distress is measured by number of individuals who experienced it.'}, {'measure': 'Clinically Significant Bleeding', 'timeFrame': '3 months', 'description': 'Clinically significant bleeding distress is measured by number of individuals who experienced it.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mild Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'This is a double-blind, randomized controlled trial comparing the effect of omega-3 fatty acid versus placebo on blood biomarkers of brain injury, inflammation and neurogenesis.', 'detailedDescription': 'Primary brain injury, the initial physical injury to brain tissue post-trauma, responds only to measures that prevent TBI from occurring in the first place. However, secondary brain injury, a complex cascade of events causing additional brain injury following primary brain injury, is more amenable to pharmacologic treatment. Neuroinflammation is one of the recognized mechanisms of secondary brain injury. In response to primary brain injury, activated microglia and injured neurons both release signaling proteins including cytokines and chemokines. Ω-3 and ω-6 fatty acids are major components of immune cells and neuronal cell membranes. They are also precursors to neuromodulatory lipids such as eicodanoids, endovanilloids and endocannabinoids that have antinociceptive and anxiolytic properties. Docosahexaenoic acid (DHA) is one of the most abundant fatty acid components of brain cell membrane phospholipids. In rodent model studies, dietary supplementation with omega-3 fatty acids (eicosapentaenoic acid \\[EPA\\] and docosahexaenoic acid \\[DHA\\]) decreased secondary axonal injury, attenuated endoplasmic reticulum stress response, decreased neuroinflammation post-TBI, and improved short and long-term neurologic outcomes. Additionally, DHA supplementation post-TBI enhances neurogenesis by counteracting reductions in neuroplasticity biomarkers such as brain-derived neurotrophic factor. Furthermore, DHA deficient rodents are more likely to have a greater amount of axonal injury and slower recovery neurologic recovery post-TBI. To our knowledge there are no human studies examining the effect of omega-3 fatty acid supplementation post-TBI on functional, symptomatic and neurologic outcomes. However, a study of collegiate football players who were randomized to 2, 4 or 6g/day of DHA or placebo for a total of 189 days (including 80 pre-season days). Irrespective of the dose of DHA supplementation, those receiving DHA had lower values of serum neurofilament light chain, a biomarker of axonal injury, than those receiving placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Individuals presenting to the emergency department (ED) within 24 hours of injury, who meet the American Congress of Rehabilitation Medicine (ACRM)'s definition of having mild traumatic brain injury (mTBI) will be eligible\n* The ACRM defines mTBI as a traumatically-induced physiological disruption of brain function as a consequence of the head being struck, striking an object, or undergoing an acceleration/deceleration movement without direct external head trauma and resulting in at least one of the following:\n* any period of loss of consciousness (LOC)\n* any loss of memory for events immediately before or after the injury\n* any alteration in mental state at the time of the injury (eg, feeling dazed, disoriented, or confused)\n* focal neurological deficit(s) that may or may not be transient\n\nExclusion Criteria:\n\n* GCS\\<13 at any time during ED stay.\n* Significant polytrauma including: bony fracture or solid organ injury\n* Study medication cannot be administered within 24 hours of injury\n* Patient cannot be relied on to complete follow-up (i.e. no reliable telephone number, substance dependence, homeless)\n* Cannot communicate in English\n* Take an anticoagulant (coumadin or a novel oral anticoagulant) daily\n* Age less than 18 years or greater than 65 years\n* Patients already taking fish oil supplements daily\n* History of cognitive impairment\n* Allergic to fish/fish oil\n* Pregnant women (self-reported)"}, 'identificationModule': {'nctId': 'NCT03345550', 'acronym': 'OPTIMA', 'briefTitle': 'OPTIMA-TBI Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Pilot Study of Omega-3 Polyunsaturated Fatty Acid Treatment in Mild Acute TBI (OPTIMA-TBI Pilot)', 'orgStudyIdInfo': {'id': 'HUM00129045'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Omega-3 Polyunsaturated Fatty Acid Treatment Arm', 'description': 'Participants randomized to this study arm will receive 6g DHA+EPA for one month followed by 1.2 g DHA+EPA for two months. Capsules contain fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules.', 'interventionNames': ['Drug: Omega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA & 100 mg EPA)) or placebo capsules.']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Arm', 'description': 'Participants randomized to this study arm will receive placebo drug for 3 months.', 'interventionNames': ['Drug: Placebo - Cap']}], 'interventions': [{'name': 'Omega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA & 100 mg EPA)) or placebo capsules.', 'type': 'DRUG', 'description': 'Participants will be randomized to receive fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules.', 'armGroupLabels': ['Omega-3 Polyunsaturated Fatty Acid Treatment Arm']}, {'name': 'Placebo - Cap', 'type': 'DRUG', 'description': 'Participants will be randomized to receive fish oil 1000 mg (contains 500 mg DHA \\& 100 mg EPA) or placebo capsules (olive oil capsules that look identical to the intervention DHA+EPA).', 'armGroupLabels': ['Placebo Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Frederick Korley, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Emergency Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Frederick Korley, MD, PhD', 'investigatorAffiliation': 'University of Michigan'}}}}