Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT00753818
Status:
COMPLETED
Last Update Posted:
2008-09-17
First Post:
2008-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Developmental Effects of Infant Formula Supplemented With LCPUFA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'lastUpdateSubmitDate': '2008-09-16', 'studyFirstSubmitDate': '2008-09-16', 'studyFirstSubmitQcDate': '2008-09-16', 'lastUpdatePostDateStruct': {'date': '2008-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual development'}], 'secondaryOutcomes': [{'measure': 'Cognitive development'}]}, 'conditionsModule': {'keywords': ['infant formula', 'visual development'], 'conditions': ['Cognitive Development', 'Growth']}, 'referencesModule': {'references': [{'pmid': '27747986', 'type': 'DERIVED', 'citation': 'Liao K, McCandliss BD, Carlson SE, Colombo J, Shaddy DJ, Kerling EH, Lepping RJ, Sittiprapaporn W, Cheatham CL, Gustafson KM. Event-related potential differences in children supplemented with long-chain polyunsaturated fatty acids during infancy. Dev Sci. 2017 Sep;20(5):10.1111/desc.12455. doi: 10.1111/desc.12455. Epub 2016 Oct 16.'}, {'pmid': '22835597', 'type': 'DERIVED', 'citation': 'Drover JR, Felius J, Hoffman DR, Castaneda YS, Garfield S, Wheaton DH, Birch EE. A randomized trial of DHA intake during infancy: school readiness and receptive vocabulary at 2-3.5 years of age. Early Hum Dev. 2012 Nov;88(11):885-91. doi: 10.1016/j.earlhumdev.2012.07.007. Epub 2012 Jul 25.'}, {'pmid': '20130095', 'type': 'DERIVED', 'citation': 'Birch EE, Carlson SE, Hoffman DR, Fitzgerald-Gustafson KM, Fu VL, Drover JR, Castaneda YS, Minns L, Wheaton DK, Mundy D, Marunycz J, Diersen-Schade DA. The DIAMOND (DHA Intake And Measurement Of Neural Development) Study: a double-masked, randomized controlled clinical trial of the maturation of infant visual acuity as a function of the dietary level of docosahexaenoic acid. Am J Clin Nutr. 2010 Apr;91(4):848-59. doi: 10.3945/ajcn.2009.28557. Epub 2010 Feb 3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effects on visual development, growth, cognitive development, tolerance, and blood chemistry parameters in term infants fed one of four study formulas containing various levels of DHA and ARA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Days', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy, term, formula fed infants from 1-5 days of age\n\nExclusion Criteria:\n\n* history of disease that effects normal growth and development\n* breast fed, or formula intolerance'}, 'identificationModule': {'nctId': 'NCT00753818', 'briefTitle': 'Developmental Effects of Infant Formula Supplemented With LCPUFA', 'nctIdAliases': ['NCT00222157'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Mead Johnson Nutrition'}, 'orgStudyIdInfo': {'id': '3370-2(-4)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Other: DHA and ARA']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Other: DHA and ARA']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Other: DHA and ARA']}, {'type': 'OTHER', 'label': '4', 'description': 'Control', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'DHA and ARA', 'type': 'OTHER', 'description': 'various levels of DHA and ARA', 'armGroupLabels': ['1', '2', '3']}, {'name': 'Control', 'type': 'OTHER', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'The University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Southwestern Medical Center at Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mead Johnson Nutrition', 'class': 'INDUSTRY'}}}}