Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-01-04 @ 8:58 AM
Study NCT ID:
NCT02092857
Status:
COMPLETED
Last Update Posted:
2014-04-25
First Post:
2014-03-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment of Arachidonic Acid Supplementation in Infant Formula on the Immune Response of Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016718', 'term': 'Arachidonic Acid'}], 'ancestors': [{'id': 'D001095', 'term': 'Arachidonic Acids'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005228', 'term': 'Fatty Acids, Essential'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tclandin@ualberta.ca', 'phone': '7804925188', 'title': 'Dr. Tom Clandinin', 'organization': 'University of Alberta'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '34 mg/100 kcal Arachidonic Acid', 'description': '10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid', 'otherNumAtRisk': 30, 'otherNumAffected': 2, 'seriousNumAtRisk': 30, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '25 mg/100 kcal Arachidonic Acid', 'description': '10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid', 'otherNumAtRisk': 30, 'otherNumAffected': 7, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Infant Formula Without Arachidonic Acid', 'description': '10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).', 'otherNumAtRisk': 29, 'otherNumAffected': 3, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'swallowing disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'gastroesophageal reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': "cow's milk intolerance", 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'inguinal hernia - male', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}], 'seriousEvents': [{'term': 'sudden unexpected infant death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Antigen-presenting B Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '34 mg/100 kcal Arachidonic Acid', 'description': '10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid'}, {'id': 'OG001', 'title': '25 mg/100 kcal Arachidonic Acid', 'description': '10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid'}, {'id': 'OG002', 'title': 'Infant Formula Without Arachidonic Acid', 'description': '10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).'}], 'classes': [{'categories': [{'measurements': [{'value': '21.9', 'groupId': 'OG000'}, {'value': '22.8', 'groupId': 'OG001'}, {'value': '25.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10 weeks', 'unitOfMeasure': 'percentage of CD20+ B cells', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '34 mg/100 kcal Arachidonic Acid', 'description': '10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid'}, {'id': 'FG001', 'title': '25 mg/100 kcal Arachidonic Acid', 'description': '10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid'}, {'id': 'FG002', 'title': 'Infant Formula Without Arachidonic Acid', 'description': '10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '34 mg/100 kcal Arachidonic Acid', 'description': '10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid'}, {'id': 'BG001', 'title': '25 mg/100 kcal Arachidonic Acid', 'description': '10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid'}, {'id': 'BG002', 'title': 'Infant Formula Without Arachidonic Acid', 'description': '10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16.8', 'spread': '3.8', 'groupId': 'BG000'}, {'value': '16.5', 'spread': '3.8', 'groupId': 'BG001'}, {'value': '17.8', 'spread': '4.4', 'groupId': 'BG002'}, {'value': '17', 'spread': '1.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-24', 'studyFirstSubmitDate': '2014-03-18', 'resultsFirstSubmitDate': '2014-03-24', 'studyFirstSubmitQcDate': '2014-03-18', 'lastUpdatePostDateStruct': {'date': '2014-04-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-24', 'studyFirstPostDateStruct': {'date': '2014-03-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Antigen-presenting B Cells', 'timeFrame': '10 weeks'}]}, 'conditionsModule': {'keywords': ['nutrient', 'nutrition', 'arachidonic acid', 'essential fatty acids'], 'conditions': ['Focus: Nutritional Requirements for Infants']}, 'descriptionModule': {'briefSummary': 'The immune system of newborn infants is immature with low activity of both innate and acquired immune reactions. Early nutrition has an impact on early immune responses. Dietary fatty acids are one nutritional factor noted to play a role in immune function. The omega-6 long-chain polyunsaturated fatty acid, ARA (Arachidonic acid) and the omega-3 fatty acid, DHA (docosahexaenoic acid) are found naturally in breastmilk and some infant formulas. The balance or relative amounts of ARA and DHA have been associated with immune response. Some commercial infant formula contains both ARA and DHA. However, the optimal balance of ARA and DHA has not been determined with respect to immune function. This study will assess two levels of ARA and the impact on immune response in healthy, term infants and whether genes that influence essential fatty acid metabolism alter the nutritional requirement of infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '21 Days', 'minimumAge': '14 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* healthy term infants\n* birth weight, length and head circumference between the 5th and 95th percentile for gestational age (according to the National Center for Health Statistics growth charts)\n* receiving \\>80% for their intake by mouth from commercial infant formula\n* low-risk for allergy based on a negative family history.\n\nExclusion criteria:\n\n* corticosteroid use\n* red cell or plasma transfusions\n* IV lipid emulsions prior to study entry\n* major congenital malformations\n* systemic or congenital infection\n* significant neonatal morbidity\n* maternal autoimmune disorders\n* acute illness precluding oral feedings or conditions requiring feedings other than standard formula'}, 'identificationModule': {'nctId': 'NCT02092857', 'briefTitle': 'Assessment of Arachidonic Acid Supplementation in Infant Formula on the Immune Response of Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Assessment of Arachidonic Acid Supplementation in Infant Formula on the Immune Response of Infants', 'orgStudyIdInfo': {'id': 'Pro00005583'}, 'secondaryIdInfos': [{'id': '230831', 'type': 'OTHER_GRANT', 'domain': 'CIHR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '34 mg/100 kcal arachidonic acid', 'description': '10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid', 'interventionNames': ['Dietary Supplement: Arachidonic acid (34 mg/100 kcal)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '25 mg/100 kcal arachidonic acid', 'description': '10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid', 'interventionNames': ['Dietary Supplement: Arachidonic acid (25 mg/100 kcal )']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Infant formula without arachidonic acid', 'description': '10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Arachidonic acid (25 mg/100 kcal )', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['25 mg/100 kcal arachidonic acid']}, {'name': 'Arachidonic acid (34 mg/100 kcal)', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['34 mg/100 kcal arachidonic acid']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).', 'armGroupLabels': ['Infant formula without arachidonic acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Michael T Clandinin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mead Johnson Nutrition', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}