Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT00770627
Status:
UNKNOWN
Last Update Posted:
2010-04-13
First Post:
2008-10-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate the Efficacy and the Tolerance of an Omega 3 Fatty Acids Supplementation in ADHD Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-04-12', 'studyFirstSubmitDate': '2008-10-09', 'studyFirstSubmitQcDate': '2008-10-09', 'lastUpdatePostDateStruct': {'date': '2010-04-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ADHD rating scale', 'timeFrame': '5 minutes'}], 'secondaryOutcomes': [{'measure': "Conners (parents, 48 items), CDI (Depression), Tête de l'alouette (lexical capacity), KITAP Battery (Attentional capacity)", 'timeFrame': '3 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['160 children', 'parallel group'], 'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'referencesModule': {'references': [{'pmid': '37058600', 'type': 'DERIVED', 'citation': 'Gillies D, Leach MJ, Perez Algorta G. Polyunsaturated fatty acids (PUFA) for attention deficit hyperactivity disorder (ADHD) in children and adolescents. Cochrane Database Syst Rev. 2023 Apr 14;4(4):CD007986. doi: 10.1002/14651858.CD007986.pub3.'}]}, 'descriptionModule': {'briefSummary': "Principal focus is to evaluate the effects of omega 3 fatty acids supplementation on the ADHD children's behaviour during 12 weeks on two years. The secondary focus is to evaluate the effects of omega 3 fatty acids supplementation on the lexical level,intentional abilities, anxiety and depression.\n\nThe omega 3 fatty acids don't present adverse side effects. The inclusion to the trial could avoid the intake the methylphenidate and its associated adverse side effects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 6 to 15 years and 11 months of age ADHD children with hyperactivity confirmed dy DSM IV criteria Children and parents' consent\n\nExclusion Criteria:\n\n* Without methylphenidate treatment Fish or other sea products allergic Intake of sea omega 3 fatty acids supplments more one week during 3 months before the trial Children need quickly to take methylphenidate: social, family, or school risk Intake methylphenidate 30 days before the trial or/and intake it during one consecutive week"}, 'identificationModule': {'nctId': 'NCT00770627', 'briefTitle': 'Clinical Trial to Evaluate the Efficacy and the Tolerance of an Omega 3 Fatty Acids Supplementation in ADHD Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laboratoires URGO'}, 'officialTitle': 'A Randomized , Controlled, Doulbe Blind Placebo Trial To Evaluate The Efficacy and the Tolerance of an Omega 3 Fatty Acids Supplementation in ADHD Children', 'orgStudyIdInfo': {'id': 'F-08-08-3103039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo caps', 'interventionNames': ['Dietary Supplement: Omega 3 caps']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Omega 3 caps', 'interventionNames': ['Dietary Supplement: Omega 3 caps']}], 'interventions': [{'name': 'Omega 3 caps', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Children between 6 and 8 years must take 2 caps/day Children between 9 and 11 years must take 3 caps/day Children between 12 and 15 years must take 4 caps /day', 'armGroupLabels': ['Omega 3 caps', 'Placebo caps']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69677', 'city': 'Bron', 'country': 'France', 'facility': 'Clinical Investigation Center', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '69677', 'city': 'Bron', 'country': 'France', 'facility': 'Hopital Cardiovasculaire Louis Pradel', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laboratoires URGO', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Doctor Olivier Revol', 'oldOrganization': 'Pierre Wertheimer Hospital'}}}}