Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-01-01 @ 1:19 AM
Study NCT ID:
NCT00820833
Status:
COMPLETED
Last Update Posted:
2015-03-26
First Post:
2009-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Formula on Growth of Infants From Overweight or Obese Mothers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-25', 'studyFirstSubmitDate': '2009-01-08', 'studyFirstSubmitQcDate': '2009-01-08', 'lastUpdatePostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean weight gain', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'blood test assessments; body composition, bone density', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['infant formula', 'obesity', 'growth'], 'conditions': ['Infant Nutrition']}, 'referencesModule': {'references': [{'pmid': '24637965', 'type': 'DERIVED', 'citation': 'Inostroza J, Haschke F, Steenhout P, Grathwohl D, Nelson SE, Ziegler EE. Low-protein formula slows weight gain in infants of overweight mothers. J Pediatr Gastroenterol Nutr. 2014 Jul;59(1):70-7. doi: 10.1097/MPG.0000000000000349.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether infants, from overweight or obese mothers, fed a formula with proteins and calories different than a standard infant formula have a different growth'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '3 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* healthy newborn infant\n* birth weight between 2500g and 4800g\n* singleton birth\n* mother's BMI before pregnancy was between 26 and 25\n* for the breastfeeding group: mother has elected to exclusively breastfeed her baby from birth to at least 6 months of age\n* for the formula groups: mother has elected to exclusively formula feed her baby from 3 to 6 months of age\n* having obtained signed informed consent of legal representative\n\nExclusion Criteria:\n\n* body weight smaller than 5th percentile for that gestational age\n* newborn whose mother has diabetes\n* newborn whose mother has a drug dependence during pregnancy\n* newborn currently participating in another trial"}, 'identificationModule': {'nctId': 'NCT00820833', 'briefTitle': 'Effect of Formula on Growth of Infants From Overweight or Obese Mothers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Effect of Protein Levels and Caloric Density on the Growth of Formula Fed Infants From Overweight or Obese Mothers', 'orgStudyIdInfo': {'id': '05.29.INF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Standard infant formula', 'interventionNames': ['Other: standard infant formula']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Test formula', 'interventionNames': ['Other: Test formula']}, {'type': 'NO_INTERVENTION', 'label': '3', 'description': 'Breastfeeding reference group'}], 'interventions': [{'name': 'standard infant formula', 'type': 'OTHER', 'description': 'standard infant formula given from 3 to 12 months of age, as per standard requirement', 'armGroupLabels': ['1']}, {'name': 'Test formula', 'type': 'OTHER', 'description': 'Test formula with different protein and calorie content than standard formula, given from 3 to 12 months of age. As per standard requirement.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Temuco', 'country': 'Chile', 'facility': 'Departamento de Medicina Interna, University de la Frontera', 'geoPoint': {'lat': -38.73628, 'lon': -72.59738}}], 'overallOfficials': [{'name': 'Jaime Inostroza, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de La Frontera'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}