Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-02-18 @ 6:03 PM
Study NCT ID:
NCT02440503
Status:
COMPLETED
Last Update Posted:
2017-10-26
First Post:
2014-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
How Infant Diets Would Affect Growth in Early Childhood
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'stool samples will be collected for microbiome analysis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-24', 'studyFirstSubmitDate': '2014-06-25', 'studyFirstSubmitQcDate': '2015-05-06', 'lastUpdatePostDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Age adjusted height', 'timeFrame': "Day 1: one time assessment during the participant's visit to Colorado Children's hospital", 'description': "observational, one time assessment. The hospital visit is scheduled according to the participant's availability."}, {'measure': 'Age adjusted weight', 'timeFrame': "Day 1: one time assessment during the participant's visit to Colorado Children's hospital", 'description': "observational, one time assessment. The hospital visit is scheduled according to the participant's availability."}], 'secondaryOutcomes': [{'measure': 'Percent body fat', 'timeFrame': "Day 1: one time assessment during the participant's visit to Colorado Children's hospital", 'description': 'Body composition using DEXA scan will be assessed during the hospital visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Growth', 'Body Composition', 'Gut Health']}, 'descriptionModule': {'briefSummary': "The investigators research group conducted a feeding study in 2012 (IRB 07-0003) that included breastfed infants consuming different infant solid foods. The investigators results showed that different solid foods, especially the protein content of the food, is important on infant's gut bacteria profile and growth. Although the first year of life is critical in obesity development later in life, data are very limited on the effect of protein from solid foods, an important component of infant diet, especially in breast-fed infants. In this study, the investigators will re-contact these participants, who are now in their early childhood (\\~5 years old), to evaluate the long-term effect of various macronutrient quantities in solid foods, by assessing the participants' growth, body composition, and gut bacteria profile."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children 4-6 years of age', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Those participants who completed the initial trial when they were infants.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02440503', 'acronym': 'FYI-FU', 'briefTitle': 'How Infant Diets Would Affect Growth in Early Childhood', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Effect of Complementary Feeding With Different Macronutrient Quantities on Growth and Body Composition: a Follow-up Trial', 'orgStudyIdInfo': {'id': '14-0489'}, 'secondaryIdInfos': [{'id': 'UL1TR001082', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR001082', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'UC Denver', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Minghua Tang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}