Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2026-03-27 @ 2:41 AM
Study NCT ID:
NCT00616395
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-02
First Post:
2007-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Early Infant Diet on Growth and Development
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma, urine, and stool may be collected from some study participants.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2002-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2007-12-31', 'studyFirstSubmitQcDate': '2008-02-14', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Growth and development', 'timeFrame': 'yearly, 1-6 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Infant Nutrition', 'Soy Phytochemicals', 'Infant Body Composition', 'Brain Function', 'Cognition and Development', 'Healthy Infants'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '37028556', 'type': 'DERIVED', 'citation': 'Chen JR, Samuel HA, Shlisky J, Sims CR, Lazarenko OP, Williams DK, Andres A, Badger TM. A longitudinal observational study of skeletal development between ages 3 mo and 6 y in children fed human milk, milk formula, or soy formula. Am J Clin Nutr. 2023 Jun;117(6):1211-1218. doi: 10.1016/j.ajcnut.2023.04.002. Epub 2023 Apr 5.'}, {'pmid': '32961547', 'type': 'DERIVED', 'citation': 'Sobik S, Sims CR, McCorkle G, Bellando J, Sorensen ST, Badger TM, Casey PH, Williams DK, Andres A. Early infant feeding effect on growth and body composition during the first 6 years and neurodevelopment at age 72 months. Pediatr Res. 2021 Jul;90(1):140-147. doi: 10.1038/s41390-020-01157-z. Epub 2020 Sep 22.'}, {'pmid': '32330237', 'type': 'DERIVED', 'citation': 'Brink LR, Mercer KE, Piccolo BD, Chintapalli SV, Elolimy A, Bowlin AK, Matazel KS, Pack L, Adams SH, Shankar K, Badger TM, Andres A, Yeruva L. Neonatal diet alters fecal microbiota and metabolome profiles at different ages in infants fed breast milk or formula. Am J Clin Nutr. 2020 Jun 1;111(6):1190-1202. doi: 10.1093/ajcn/nqaa076.'}, {'pmid': '25761499', 'type': 'DERIVED', 'citation': 'Andres A, Moore MB, Linam LE, Casey PH, Cleves MA, Badger TM. Compared with feeding infants breast milk or cow-milk formula, soy formula feeding does not affect subsequent reproductive organ size at 5 years of age. J Nutr. 2015 May;145(5):871-5. doi: 10.3945/jn.114.206201. Epub 2015 Mar 11.'}, {'pmid': '23375908', 'type': 'DERIVED', 'citation': "Andres A, Casey PH, Cleves MA, Badger TM. Body fat and bone mineral content of infants fed breast milk, cow's milk formula, or soy formula during the first year of life. J Pediatr. 2013 Jul;163(1):49-54. doi: 10.1016/j.jpeds.2012.12.067. Epub 2013 Feb 1."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to characterize physical growth, body composition, dietary intake, neurobehavioral development, and brain function of infants and children fed mostly breast-milk, milk-based formula or soy-based formula during their first year of life. Children are followed from age 2 months to age 6 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy infants', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Infants\n* Birth weight = 6 to 9 lbs\n* Mostly fed breast milk, milk-based formula, soy-based formula\n* Mother over 18 years of age\n\nExclusion Criteria:\n\n* Unhealthy pregnancy\n* Illness during pregnancy or for the child that could interfere with the study parameters'}, 'identificationModule': {'nctId': 'NCT00616395', 'acronym': 'Beginnings', 'briefTitle': 'Study of Early Infant Diet on Growth and Development', 'organization': {'class': 'OTHER', 'fullName': "Arkansas Children's Hospital Research Institute"}, 'officialTitle': 'Effects of Diet on Metabolism, Body Composition, Brain Function in Infants/Children', 'orgStudyIdInfo': {'id': '07130'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'no grouping', 'description': 'IDE used for outcome measurement not for an intervention.', 'interventionNames': ['Device: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'DEVICE', 'armGroupLabels': ['no grouping']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Nutrition Center", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Aline Andres, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arkansas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Arkansas Children's Hospital Research Institute", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}