Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-28 @ 1:33 AM
Study NCT ID:
NCT01154894
Status:
COMPLETED
Last Update Posted:
2011-06-23
First Post:
2010-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Fatty Acids Improve Social Impairment in Autism Spectrum Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-22', 'studyFirstSubmitDate': '2010-06-30', 'studyFirstSubmitQcDate': '2010-06-30', 'lastUpdatePostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aberrant Behavior Checklist-community (ABC)', 'timeFrame': 'Pretreatment and at 4 weeks after intervention for 16-weeks trial', 'description': 'ABC is used to estimate abnormal behavior, including 5 subscales, irritability, social withdrawal, stereotypy, hyperactivity, and inappropriate speech'}], 'secondaryOutcomes': [{'measure': 'Social Responsiveness Scale (SRS)', 'timeFrame': 'pretreatment and at 4 weeks after intervention for 16-weeks trial', 'description': 'The SRS is assessed the severity of social communication impairment in any population.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['arachidonic acid', 'autism spectrum disorders', 'social interaction', 'randomized controlled trial', 'DHA'], 'conditions': ['Autism Spectrum Disorders']}, 'referencesModule': {'references': [{'pmid': '22370992', 'type': 'DERIVED', 'citation': 'Yui K, Koshiba M, Nakamura S, Kobayashi Y. Effects of large doses of arachidonic acid added to docosahexaenoic acid on social impairment in individuals with autism spectrum disorders: a double-blind, placebo-controlled, randomized trial. J Clin Psychopharmacol. 2012 Apr;32(2):200-6. doi: 10.1097/JCP.0b013e3182485791.'}]}, 'descriptionModule': {'briefSummary': 'In a double-blind, placebo-controlled 16-week trial investigators administered daily doses of either youths with autism spectrum disorders.ARA and DHA supplementation significantly improved communication as well as social withdrawal symptoms. This pilot study provides the first evidence that supplementation with larger ARA doses added to DHA improve impaired social interaction in youths with Autism Spectrum Disorders (ASD).', 'detailedDescription': "We recruited 13 individuals who met the DSM-IV criteria for a diagnosis of high functioning autistic disorder (n=1) or Asperger's Disorder (n=12),corroborated by the Autism Diagnostic Interview-Revised. Participants were free of any medical or comorbid psychiatric disorders. Other inclusion criteria included weigh of at least 16 kg, either a verbal or performance intelligence quotient (IQ) above 80, and a score greater than 10 on the social withdrawal subscale of the Aberrant Behavior Checklist-Community."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '29 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of high functioning autistic disorder or Asperger's Disorder. Free of any medical or comorbid psychiatric disorders.\n\nExclusion Criteria:\n\n* Any medical treatment for other psychiatric disorders"}, 'identificationModule': {'nctId': 'NCT01154894', 'acronym': 'Fatty acid', 'briefTitle': 'Dietary Fatty Acids Improve Social Impairment in Autism Spectrum Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Ashiya University'}, 'officialTitle': 'Double-blind Randomized Placebo-controlled Trail', 'orgStudyIdInfo': {'id': 'KunioYui'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo-controlled trial', 'interventionNames': ['Other: Aravita including arachidonic acid and docosaheaenoic acid']}], 'interventions': [{'name': 'Aravita including arachidonic acid and docosaheaenoic acid', 'type': 'OTHER', 'description': 'Nine of 13 Participants were treated with 6 capsules of Aravita per day for 16-week trial, remaining 4 participants aged under 12 years received 3 capsules per day.', 'armGroupLabels': ['Placebo-controlled trial']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ashiya University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kunio Yui', 'oldOrganization': 'Ashiya University'}}}}