Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT03487094
Status:
COMPLETED
Last Update Posted:
2020-07-10
First Post:
2018-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Growth and Tolerance of Infants Fed Formula for 16 Weeks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D041943', 'term': 'Infant Formula'}], 'ancestors': [{'id': 'D041941', 'term': 'Milk Substitutes'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D005526', 'term': 'Food, Formulated'}, {'id': 'D019648', 'term': 'Foods, Specialized'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D007225', 'term': 'Infant Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Eligible infants are randomized to commercial control or experimental product.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multi-Investigator, Prospective, Randomized Clinical Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-09', 'studyFirstSubmitDate': '2018-03-27', 'studyFirstSubmitQcDate': '2018-03-27', 'lastUpdatePostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Growth', 'timeFrame': '16 weeks', 'description': 'Weight Gain'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Child Development']}, 'descriptionModule': {'briefSummary': 'Growth and Tolerance Trial of Iron-fortified infant formulas', 'detailedDescription': '16 WEEK GROWTH AND TOLERANCE'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Days', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy term infants, 37-42 weeks gestational age\n\nExclusion Criteria:\n\n* Any condition that would negatively impact assessment of growth and tolerance'}, 'identificationModule': {'nctId': 'NCT03487094', 'briefTitle': 'Growth and Tolerance of Infants Fed Formula for 16 Weeks', 'organization': {'class': 'INDUSTRY', 'fullName': "Nature's One"}, 'officialTitle': 'Growth Monitoring Study of Infants Fed Formula for 16 Weeks', 'orgStudyIdInfo': {'id': 'N1.2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Growth, Tolerance of Infants-Exp', 'description': 'Infant Formula', 'interventionNames': ['Other: Infant formula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Growth,Tolerance of Infants-Com', 'description': 'Infant Formula', 'interventionNames': ['Other: Infant formula']}], 'interventions': [{'name': 'Infant formula', 'type': 'OTHER', 'description': 'Multi-centered, prospective, randomized clinical trial', 'armGroupLabels': ['Growth, Tolerance of Infants-Exp', 'Growth,Tolerance of Infants-Com']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Visions Clinical Research-Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72112', 'city': 'Newport', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Harris Pediatric Clinic', 'geoPoint': {'lat': 35.6048, 'lon': -91.2818}}, {'zip': '72143', 'city': 'Searcy', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Searcy Medical Center', 'geoPoint': {'lat': 35.25064, 'lon': -91.73625}}, {'zip': '06360', 'city': 'Norwich', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Norwich Pediatric Group, PC', 'geoPoint': {'lat': 41.52426, 'lon': -72.07591}}, {'zip': '33483', 'city': 'Delray Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Pediatrics by the Sea', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'zip': '32746', 'city': 'Lake Mary', 'state': 'Florida', 'country': 'United States', 'facility': 'Altamonte Pediatric Associates', 'geoPoint': {'lat': 28.75888, 'lon': -81.31784}}, {'zip': '33175', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'New Horizon Research Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30349', 'city': 'College Park', 'state': 'Georgia', 'country': 'United States', 'facility': 'Paramount Research Solutions', 'geoPoint': {'lat': 33.65344, 'lon': -84.44937}}, {'zip': '47715', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Qualmedica Research', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '43201', 'city': 'Owensboro', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Qualmedica Research', 'geoPoint': {'lat': 37.77422, 'lon': -87.11333}}, {'zip': '71105', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Portico Pediatrics', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '21108', 'city': 'Millersville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Gvozden Pediatrics', 'geoPoint': {'lat': 39.05955, 'lon': -76.64802}}, {'zip': '11580', 'city': 'Valley Stream', 'state': 'New York', 'country': 'United States', 'facility': 'Valley Stream Pediatrics_Lashley', 'geoPoint': {'lat': 40.66427, 'lon': -73.70846}}, {'zip': '28304', 'city': 'Fayetteville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Institute for Clinical Research', 'geoPoint': {'lat': 35.05266, 'lon': -78.87836}}, {'zip': '27609', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pediatric Partners', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '28625', 'city': 'Statesville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Piedmont Healthcare', 'geoPoint': {'lat': 35.78264, 'lon': -80.8873}}, {'zip': '43123', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Aventiv Research, Inc', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '45414', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Pediatric Research Association', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '44145', 'city': 'Westlake', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cynthia Strieter-Boland, MD', 'geoPoint': {'lat': 41.45532, 'lon': -81.91792}}, {'zip': '19020', 'city': 'Bensalem', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Red Lion Pediatrics', 'geoPoint': {'lat': 40.10455, 'lon': -74.95128}}, {'zip': '29414', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Coastal Pediatric Associates', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29406', 'city': 'North Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Coastal Pediatric Research', 'geoPoint': {'lat': 32.85462, 'lon': -79.97481}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': "Southwestern Children's Research Associates, PA", 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22902', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Pediatric Research of Charlottesville, LLC', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Robert D Murray, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Consultant'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nature's One", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}