Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-30 @ 1:29 PM
Study NCT ID:
NCT04312932
Status:
COMPLETED
Last Update Posted:
2025-11-13
First Post:
2020-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fatty Acid Supplementation in Children With ASD (Study 2)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sarah.keim@nationwidechildrens.org', 'phone': '614-722-2000', 'title': 'Sarah Keim', 'organization': "Nationwide Children's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This trial may have been underpowered to detect a clinically meaningful effect on autism symptoms. 90 days is short and this may have precluded observing effects. The focus on children with confirmed autism diagnoses and English language limit the generalizability to older or non-English speaking children or those with subclinical autistic traits. The single site-specific context may not be representative of other settings. Compliance with consuming the daily supplement was challenging.'}}, 'adverseEventsModule': {'timeFrame': '90 days', 'description': 'Safety Monitoring Uniform Report Form (SMURF)', 'eventGroups': [{'id': 'EG000', 'title': 'GLA + EPA + DHA Group', 'description': '50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days\n\nLCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 45, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Canola Oil Group', 'description': 'Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 46, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Chest or breathing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 42, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 41, 'numAffected': 25}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ears', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Energy level', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Genitourinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal and eating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 63, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 77, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mouth lips teeth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal and movement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nose, sinus, throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 46, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 47, 'numAffected': 26}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin or hair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sleep', 'stats': [{'groupId': 'EG000', 'numAtRisk': 48, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 48, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pervasive Developmental Disorder Behavior Inventory (PDDBI) - Autism Composite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Long Chain Polyunsaturated Fatty Acid (LCPUFA) Oil Supplement', 'description': '25 mg/kg, 50 mg/kg, or 75 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days\n\nLCPUFA Oil Supplement: 25 mg/kg, 50 mg/kg, or 75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days'}, {'id': 'OG001', 'title': 'Canola Oil', 'description': 'Equal volume (25 mg/kg, 50 mg/kg, or 75 mg/kg) of placebo (canola) oil to be administered twice per day by mouth for 90 days\n\nCanola Oil Placebo: Equal volume (25 mg/kg, 50 mg/kg, or 75 mg/kg) of placebo (canola) oil to be administered twice per day by mouth for 90 days'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '115.5', 'spread': '32.5', 'groupId': 'OG000'}, {'value': '106.5', 'spread': '34.6', 'groupId': 'OG001'}]}]}, {'title': '90 days post randomization (End of Trial)', 'categories': [{'measurements': [{'value': '98.1', 'spread': '34.1', 'groupId': 'OG000'}, {'value': '91.4', 'spread': '36.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 90 days post randomization.', 'description': 'Change in PDDBI Autism Composite raw score. This scale measures the severity and nature of autism symptoms. Autism Composite raw scores range -31 to 262. Higher scores indicate greater severity. We omitted the Semantic/Pragmatic Problems subscale from the calculation of the PDD autism composite raw score because including that subscale penalizes children who are nonverbal at baseline but gain language during the study.', 'unitOfMeasure': 'raw score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Adaptive Behavior Composite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GLA + EPA + DHA Group', 'description': '50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days\n\nLCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days'}, {'id': 'OG001', 'title': 'Canola Oil Group', 'description': 'Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '280.3', 'spread': '99.89', 'groupId': 'OG000'}, {'value': '277.1', 'spread': '114.8', 'groupId': 'OG001'}]}]}, {'title': '90 days post randomization (End of Trial)', 'categories': [{'measurements': [{'value': '303.6', 'spread': '116.9', 'groupId': 'OG000'}, {'value': '290.0', 'spread': '120.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 90 days post randomization (End of Trial)', 'description': 'Change in adaptive behavior composite score. These are raw scores. Each one is a sum of its component subdomain raw scores. Lower scores indicate lower adaptive level. Scores range 0-634.', 'unitOfMeasure': 'raw score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pervasive Developmental Disorder (PDD) Behavior Inventory (PDDBI) - Aggressiveness Problems', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GLA + EPA + DHA Group', 'description': '50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days\n\nLCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days'}, {'id': 'OG001', 'title': 'Canola Oil Group', 'description': 'Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '26.7', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '26.5', 'spread': '13.8', 'groupId': 'OG001'}]}]}, {'title': '90 days post randomization (End of Trial)', 'categories': [{'measurements': [{'value': '23.1', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '23.8', 'spread': '13.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 90 days post randomization.', 'description': 'Change in PDDBI Aggressiveness Problems raw score. Aggressiveness domain looks at self-directed aggressive behaviors, incongruous negative affect, problems when caregiver returns from an outing, aggressiveness towards others, and overall temperament problems. Aggressiveness raw scores range from 0-60; higher scores are indicative of more aggressiveness.', 'unitOfMeasure': 'raw score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Preschool Language Scales - 5 (PLS-5) Auditory Comprehension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GLA + EPA + DHA Group', 'description': '50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days\n\nLCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days'}, {'id': 'OG001', 'title': 'Canola Oil Group', 'description': 'Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '29.4', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '28.9', 'spread': '13.6', 'groupId': 'OG001'}]}]}, {'title': '90 days post randomization (End of Trial)', 'categories': [{'measurements': [{'value': '30.3', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '30.3', 'spread': '13.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 90 days post randomization.', 'description': 'Changes in Auditory Comprehension raw score. Higher scores represent better child comprehension of language. Raw scores range 0-65 for Auditory Comprehension.', 'unitOfMeasure': 'raw score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Childhood Autism Rating Scale (CARS2) (2nd ed.)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GLA + EPA + DHA Group', 'description': '50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days\n\nLCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days'}, {'id': 'OG001', 'title': 'Canola Oil Group', 'description': 'Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '32.9', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '30.9', 'spread': '7.5', 'groupId': 'OG001'}]}]}, {'title': '90 days post randomization (End of Trial)', 'categories': [{'measurements': [{'value': '32.4', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '31.5', 'spread': '7.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 90 days post randomization.', 'description': 'Changes in Continuous Total (raw) Score. (higher scores indicate greater symptoms) Range 15-60.', 'unitOfMeasure': 'raw score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Autism Impact Measure - Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GLA + EPA + DHA Group', 'description': '50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days\n\nLCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days'}, {'id': 'OG001', 'title': 'Canola Oil Group', 'description': 'Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '222.4', 'spread': '45.5', 'groupId': 'OG000'}, {'value': '215.6', 'spread': '55.5', 'groupId': 'OG001'}]}]}, {'title': '90 days post randomization (End of Trial)', 'categories': [{'measurements': [{'value': '207.9', 'spread': '50.6', 'groupId': 'OG000'}, {'value': '200.0', 'spread': '55.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 90 days post randomization.', 'description': 'The Autism Impact Measure is a newly developed instrument for measuring change in Autism Spectrum Disorder related behaviors. (Houghton, Journal of Autism and Developmental Disorders, 2019). The Autism Impact Measure (AIM) Total Score represents the overall level of autism symptom impact across all measured domains, incorporating both the frequency and impact of symptoms. The possible range of raw scores for the AIM Total is 41 to 410. This scale measures the global severity and pervasiveness of autism-related behaviors, with higher scores indicating greater symptom impact and worse functioning, and lower scores reflecting fewer symptoms and better functioning.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Preschool Language Scales-5 Expressive Communication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GLA + EPA + DHA Group', 'description': '50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days\n\nLCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days'}, {'id': 'OG001', 'title': 'Canola Oil Group', 'description': 'Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.'}], 'classes': [{'title': 'baseline day 0', 'categories': [{'measurements': [{'value': '31.0', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '28.8', 'spread': '10.5', 'groupId': 'OG001'}]}]}, {'title': 'end of trial day 90', 'categories': [{'measurements': [{'value': '31.2', 'spread': '12.2', 'groupId': 'OG000'}, {'value': '30.7', 'spread': '11.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (day 0) to end of trial (90 days)', 'description': 'Changes in Expressive Communication raw score. Higher scores represent better child ability to communicate with others. Raw scores range 0-67.', 'unitOfMeasure': 'raw score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Preschool Language Scales-5 Total Language', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GLA + EPA + DHA Group', 'description': '50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days\n\nLCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days'}, {'id': 'OG001', 'title': 'Canola Oil Group', 'description': 'Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.'}], 'classes': [{'title': 'baseline day 0', 'categories': [{'measurements': [{'value': '60.4', 'spread': '25.3', 'groupId': 'OG000'}, {'value': '57.6', 'spread': '23.2', 'groupId': 'OG001'}]}]}, {'title': 'end of trial day 90', 'categories': [{'measurements': [{'value': '61.5', 'spread': '26.6', 'groupId': 'OG000'}, {'value': '61.0', 'spread': '25.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (day 0) to end of trial (90 days)', 'description': 'Changes in Total Language raw score (sum of Auditory Comprehension and Expressive Communication raw scores). Higher scores represent better communication ability. Raw scores range 0-131.', 'unitOfMeasure': 'raw score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Autism Impact Measure - Restricted Behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GLA + EPA + DHA Group', 'description': '50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days\n\nLCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days'}, {'id': 'OG001', 'title': 'Canola Oil Group', 'description': 'Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '43.3', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '43', 'spread': '14.3', 'groupId': 'OG001'}]}]}, {'title': '90 days post randomization (End of Trial)', 'categories': [{'measurements': [{'value': '40.3', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '38.3', 'spread': '12.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 90 days post randomization.', 'description': 'The Autism Impact Measure (AIM) Repetitive Behavior Score assesses repetitive movements, rituals, and restricted interests, capturing both how often these behaviors occur and how much they affect daily life. The possible range of raw scores for this scale is 16 to 80. It measures the frequency and impact of repetitive behaviors, with higher scores reflecting more frequent and disruptive behaviors and poorer functioning.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Autism Impact Measure - Communication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GLA + EPA + DHA Group', 'description': '50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days\n\nLCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days'}, {'id': 'OG001', 'title': 'Canola Oil Group', 'description': 'Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '36.4', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '37.1', 'spread': '10.1', 'groupId': 'OG001'}]}]}, {'title': '90 days post randomization (End of Trial)', 'categories': [{'measurements': [{'value': '32.9', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '35.4', 'spread': '10.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 90 days post randomization.', 'description': 'The Autism Impact Measure (AIM) Communication Score evaluates expressive and receptive communication skills, taking into account both the frequency of communication challenges and their impact on functioning. The possible range of raw scores for this scale is 12 to 60. It measures how effectively an individual communicates, with higher scores indicating greater communication difficulties and worse functioning.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Autism Impact Measure - Atypical Behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GLA + EPA + DHA Group', 'description': '50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days\n\nLCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days'}, {'id': 'OG001', 'title': 'Canola Oil Group', 'description': 'Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '30.2', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '29.5', 'spread': '9.4', 'groupId': 'OG001'}]}]}, {'title': '90 days post randomization (End of Trial)', 'categories': [{'measurements': [{'value': '28.7', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '26', 'spread': '9.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 90 days post randomization.', 'description': 'The Autism Impact Measure (AIM) Atypical Behavior Score captures unusual sensory responses, emotional regulation difficulties, and other atypical behaviors, assessing both how often these behaviors occur and how much they interfere with daily life. The possible range of raw scores for this scale is 12 to 60. It measures the presence and impact of atypical behaviors, with higher scores indicating more frequent or intense atypical behaviors and poorer functioning.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Autism Impact Measure - Social Reciprocity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GLA + EPA + DHA Group', 'description': '50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days\n\nLCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days'}, {'id': 'OG001', 'title': 'Canola Oil Group', 'description': 'Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '26.8', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '25.5', 'spread': '7.9', 'groupId': 'OG001'}]}]}, {'title': '90 days post randomization (End of Trial)', 'categories': [{'measurements': [{'value': '25.4', 'spread': '7', 'groupId': 'OG000'}, {'value': '24.3', 'spread': '8.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 90 days post randomization.', 'description': 'The Autism Impact Measure (AIM) Social Reciprocity Score assesses social engagement, emotional responsiveness, and reciprocal interactions, considering both the frequency and impact of social difficulties. The possible range of raw scores for this scale is 10 to 50. It measures social responsiveness and connectedness, with higher scores indicating greater social difficulty and worse functioning.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Autism Impact Measure - Peer Interaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GLA + EPA + DHA Group', 'description': '50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days\n\nLCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days'}, {'id': 'OG001', 'title': 'Canola Oil Group', 'description': 'Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '26.8', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '25.5', 'spread': '7.9', 'groupId': 'OG001'}]}]}, {'title': '90 days post randomization (End of Trial)', 'categories': [{'measurements': [{'value': '25.4', 'spread': '7', 'groupId': 'OG000'}, {'value': '24.3', 'spread': '8.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 90 days post randomization.', 'description': "The Autism Impact Measure (AIM) Peer Interaction Score evaluates social interest, initiation, and quality of interactions with peers, capturing both how often behaviors occur and how impactful they are. The possible range of raw scores for this scale is 8 to 40. It measures the child's ability to interact appropriately with peers, with higher scores indicating more challenges in peer relationships and worse functioning. for this scale is 10 to 50. Higher scores indicating greater social difficulty and worse functioning.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Communication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GLA + EPA + DHA Group', 'description': '50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days\n\nLCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days'}, {'id': 'OG001', 'title': 'Canola Oil Group', 'description': 'Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '74.2', 'spread': '39.4', 'groupId': 'OG000'}, {'value': '67.9', 'spread': '39.6', 'groupId': 'OG001'}]}]}, {'title': '90 days post randomization (End of Trial)', 'categories': [{'measurements': [{'value': '80', 'spread': '42.6', 'groupId': 'OG000'}, {'value': '73.4', 'spread': '39.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 90 days post randomization (End of Trial)', 'description': 'Change in communication score. These are raw scores. Each one is a sum of its component subdomain raw scores. Lower scores indicate lower adaptive level. Scores range 0-148.', 'unitOfMeasure': 'raw score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Socialization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GLA + EPA + DHA Group', 'description': '50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days\n\nLCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days'}, {'id': 'OG001', 'title': 'Canola Oil Group', 'description': 'Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '64.4', 'spread': '30', 'groupId': 'OG000'}, {'value': '66.1', 'spread': '34.8', 'groupId': 'OG001'}]}]}, {'title': '90 days post randomization (End of Trial)', 'categories': [{'measurements': [{'value': '67.9', 'spread': '31.8', 'groupId': 'OG000'}, {'value': '68.5', 'spread': '35.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 90 days post randomization (End of Trial)', 'description': 'Change in socialization score. These are raw scores. Each one is a sum of its component subdomain raw scores. Lower scores indicate lower adaptive level. Scores range 0-174.', 'unitOfMeasure': 'raw score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GLA + EPA + DHA Group', 'description': '50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days\n\nLCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days'}, {'id': 'FG001', 'title': 'Canola Oil Group', 'description': 'Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'GLA + EPA + DHA Group', 'description': '50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days\n\nLCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days'}, {'id': 'BG001', 'title': 'Canola Oil Group', 'description': 'Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', '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': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-04-12', 'size': 763757, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-29T14:45', 'hasProtocol': True}, {'date': '2024-04-12', 'size': 502173, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-01-29T14:48', 'hasProtocol': False}]}}, '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': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-30', 'studyFirstSubmitDate': '2020-03-16', 'resultsFirstSubmitDate': '2025-08-21', 'studyFirstSubmitQcDate': '2020-03-16', 'lastUpdatePostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-30', 'studyFirstPostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pervasive Developmental Disorder Behavior Inventory (PDDBI) - Autism Composite', 'timeFrame': 'Baseline to 90 days post randomization.', 'description': 'Change in PDDBI Autism Composite raw score. This scale measures the severity and nature of autism symptoms. Autism Composite raw scores range -31 to 262. Higher scores indicate greater severity. We omitted the Semantic/Pragmatic Problems subscale from the calculation of the PDD autism composite raw score because including that subscale penalizes children who are nonverbal at baseline but gain language during the study.'}], 'secondaryOutcomes': [{'measure': 'Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Adaptive Behavior Composite', 'timeFrame': 'Baseline to 90 days post randomization (End of Trial)', 'description': 'Change in adaptive behavior composite score. These are raw scores. Each one is a sum of its component subdomain raw scores. Lower scores indicate lower adaptive level. Scores range 0-634.'}, {'measure': 'Pervasive Developmental Disorder (PDD) Behavior Inventory (PDDBI) - Aggressiveness Problems', 'timeFrame': 'Baseline to 90 days post randomization.', 'description': 'Change in PDDBI Aggressiveness Problems raw score. Aggressiveness domain looks at self-directed aggressive behaviors, incongruous negative affect, problems when caregiver returns from an outing, aggressiveness towards others, and overall temperament problems. Aggressiveness raw scores range from 0-60; higher scores are indicative of more aggressiveness.'}, {'measure': 'Preschool Language Scales - 5 (PLS-5) Auditory Comprehension', 'timeFrame': 'Baseline to 90 days post randomization.', 'description': 'Changes in Auditory Comprehension raw score. Higher scores represent better child comprehension of language. Raw scores range 0-65 for Auditory Comprehension.'}, {'measure': 'Childhood Autism Rating Scale (CARS2) (2nd ed.)', 'timeFrame': 'Baseline to 90 days post randomization.', 'description': 'Changes in Continuous Total (raw) Score. (higher scores indicate greater symptoms) Range 15-60.'}, {'measure': 'Autism Impact Measure - Total', 'timeFrame': 'Baseline to 90 days post randomization.', 'description': 'The Autism Impact Measure is a newly developed instrument for measuring change in Autism Spectrum Disorder related behaviors. (Houghton, Journal of Autism and Developmental Disorders, 2019). The Autism Impact Measure (AIM) Total Score represents the overall level of autism symptom impact across all measured domains, incorporating both the frequency and impact of symptoms. The possible range of raw scores for the AIM Total is 41 to 410. This scale measures the global severity and pervasiveness of autism-related behaviors, with higher scores indicating greater symptom impact and worse functioning, and lower scores reflecting fewer symptoms and better functioning.'}, {'measure': 'Preschool Language Scales-5 Expressive Communication', 'timeFrame': 'Baseline (day 0) to end of trial (90 days)', 'description': 'Changes in Expressive Communication raw score. Higher scores represent better child ability to communicate with others. Raw scores range 0-67.'}, {'measure': 'Preschool Language Scales-5 Total Language', 'timeFrame': 'Baseline (day 0) to end of trial (90 days)', 'description': 'Changes in Total Language raw score (sum of Auditory Comprehension and Expressive Communication raw scores). Higher scores represent better communication ability. Raw scores range 0-131.'}, {'measure': 'Autism Impact Measure - Restricted Behavior', 'timeFrame': 'Baseline to 90 days post randomization.', 'description': 'The Autism Impact Measure (AIM) Repetitive Behavior Score assesses repetitive movements, rituals, and restricted interests, capturing both how often these behaviors occur and how much they affect daily life. The possible range of raw scores for this scale is 16 to 80. It measures the frequency and impact of repetitive behaviors, with higher scores reflecting more frequent and disruptive behaviors and poorer functioning.'}, {'measure': 'Autism Impact Measure - Communication', 'timeFrame': 'Baseline to 90 days post randomization.', 'description': 'The Autism Impact Measure (AIM) Communication Score evaluates expressive and receptive communication skills, taking into account both the frequency of communication challenges and their impact on functioning. The possible range of raw scores for this scale is 12 to 60. It measures how effectively an individual communicates, with higher scores indicating greater communication difficulties and worse functioning.'}, {'measure': 'Autism Impact Measure - Atypical Behavior', 'timeFrame': 'Baseline to 90 days post randomization.', 'description': 'The Autism Impact Measure (AIM) Atypical Behavior Score captures unusual sensory responses, emotional regulation difficulties, and other atypical behaviors, assessing both how often these behaviors occur and how much they interfere with daily life. The possible range of raw scores for this scale is 12 to 60. It measures the presence and impact of atypical behaviors, with higher scores indicating more frequent or intense atypical behaviors and poorer functioning.'}, {'measure': 'Autism Impact Measure - Social Reciprocity', 'timeFrame': 'Baseline to 90 days post randomization.', 'description': 'The Autism Impact Measure (AIM) Social Reciprocity Score assesses social engagement, emotional responsiveness, and reciprocal interactions, considering both the frequency and impact of social difficulties. The possible range of raw scores for this scale is 10 to 50. It measures social responsiveness and connectedness, with higher scores indicating greater social difficulty and worse functioning.'}, {'measure': 'Autism Impact Measure - Peer Interaction', 'timeFrame': 'Baseline to 90 days post randomization.', 'description': "The Autism Impact Measure (AIM) Peer Interaction Score evaluates social interest, initiation, and quality of interactions with peers, capturing both how often behaviors occur and how impactful they are. The possible range of raw scores for this scale is 8 to 40. It measures the child's ability to interact appropriately with peers, with higher scores indicating more challenges in peer relationships and worse functioning. for this scale is 10 to 50. Higher scores indicating greater social difficulty and worse functioning."}, {'measure': 'Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Communication', 'timeFrame': 'Baseline to 90 days post randomization (End of Trial)', 'description': 'Change in communication score. These are raw scores. Each one is a sum of its component subdomain raw scores. Lower scores indicate lower adaptive level. Scores range 0-148.'}, {'measure': 'Vineland Adaptive Behavior Scales 2nd ed. (Modified Timeframe of 90 Days) Socialization', 'timeFrame': 'Baseline to 90 days post randomization (End of Trial)', 'description': 'Change in socialization score. These are raw scores. Each one is a sum of its component subdomain raw scores. Lower scores indicate lower adaptive level. Scores range 0-174.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': 'The objective of the protocol is to test the impact of Omega 3-6 on pre-specified biological signatures (IL-1β, IL-2, and IFNγ) and to correlate changes in the biological signatures with changes in ASD symptoms.', 'detailedDescription': 'Children with ASD suffer from both mental and physical symptoms that affect quality of life and severely disrupt family well-being. The objective of the protocol is to test the impact of Omega 3-6 on pre-specified biological signatures (IL-1β, IL-2, and IFNγ) and to correlate changes in the biological signatures with changes in ASD symptoms. Fatty acid supplements are natural products with anti-inflammatory properties often used for treatment of ASD symptoms, but the efficacy remains unproven.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 2-6 years old\n* ASD diagnosis at Nationwide Children's Hospital within the prior 6 months\n* English is primary language\n\nExclusion Criteria:\n\n* Fatty acid supplementation in the past 6 months\n* Consumes fatty fish more than 3 times per week\n* Still breastfeeding or formula feeding\n* Bleeding disorder\n* Quadriparesis\n* Deafness\n* Blindness\n* Seizure disorder diagnosis\n* Autoimmune disorder including Type 1 Diabetes, Fragile X, Rett, Angelman Syndromes, Tuberous Sclerosis\n* Feeding problems precluding consumption of the supplement\n* Ingredient allergy (canola, fish, or borage seed)\n* Planned surgeries scheduled within the time frame of trial participation"}, 'identificationModule': {'nctId': 'NCT04312932', 'briefTitle': 'Fatty Acid Supplementation in Children With ASD (Study 2)', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'Fatty Acid Supplements Alter Biological Signatures and Behavior in Children With Autism Spectrum Disorder (ASD)', 'orgStudyIdInfo': {'id': 'IRB17-00517-2'}, 'secondaryIdInfos': [{'id': 'R33AT009632', 'link': 'https://reporter.nih.gov/quickSearch/R33AT009632', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Long chain polyunsaturated fatty acid (LCPUFA) Oil Supplement', 'description': '25 mg/kg, 50 mg/kg, or 75 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days', 'interventionNames': ['Drug: LCPUFA Oil Supplement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Canola Oil', 'description': 'Equal volume (25 mg/kg, 50 mg/kg, or 75 mg/kg) of placebo (canola) oil to be administered twice per day by mouth for 90 days', 'interventionNames': ['Dietary Supplement: Canola Oil Placebo']}], 'interventions': [{'name': 'LCPUFA Oil Supplement', 'type': 'DRUG', 'description': '25 mg/kg, 50 mg/kg, or 75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days', 'armGroupLabels': ['Long chain polyunsaturated fatty acid (LCPUFA) Oil Supplement']}, {'name': 'Canola Oil Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Equal volume (25 mg/kg, 50 mg/kg, or 75 mg/kg) of placebo (canola) oil to be administered twice per day by mouth for 90 days', 'armGroupLabels': ['Canola Oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Sarah Keim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nationwide Children's Hospital"}, {'name': 'Lynette Rogers, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nationwide Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sarah Keim', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sarah Keim', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}