Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-03-15 @ 6:04 AM
Study NCT ID:
NCT02587702
Status:
UNKNOWN
Last Update Posted:
2015-11-02
First Post:
2015-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Improved Formula on Fatty Acids and Mineral Metabolism in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008895', 'term': 'Milk, Human'}], 'ancestors': [{'id': 'D008892', 'term': 'Milk'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'lastUpdateSubmitDate': '2015-10-29', 'studyFirstSubmitDate': '2015-10-20', 'studyFirstSubmitQcDate': '2015-10-26', 'lastUpdatePostDateStruct': {'date': '2015-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Content of fatty acids', 'timeFrame': '3 years'}, {'measure': 'Content of calcium and magnesium', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Anthropometric measurements', 'timeFrame': '3 years', 'description': 'Index of anthropometric measurements contains weight,height and head circumference.'}, {'measure': 'Stool characteristics assessed via stool frequency', 'timeFrame': '3 years'}, {'measure': 'Stool characteristics assessed via stool consistency', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Term Infants'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether different content of β-palmitate will cause significant differences on Fatty Acids and Mineral Metabolism in Infants'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy full term infants\n\nExclusion Criteria:\n\n* experienced congenital or chromosomal disorders\n* neonatal morbidities, or metabolic illness'}, 'identificationModule': {'nctId': 'NCT02587702', 'briefTitle': 'Influence of Improved Formula on Fatty Acids and Mineral Metabolism in Infants', 'organization': {'class': 'OTHER', 'fullName': 'Beingmate Baby & Child Food Co Ltd .'}, 'orgStudyIdInfo': {'id': 'RDM2012002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Improved Infant Formula Group', 'description': 'Containing β-Palmitate Content', 'interventionNames': ['Other: β-Palmitate Content']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'General Infant Formula Group', 'description': 'Excluding β-Palmitate Content', 'interventionNames': ['Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Human Milk Group', 'description': 'Containing β-Palmitate Content Naturely in Human Milk', 'interventionNames': ['Other: β-Palmitate Content Naturely in Human Milk']}], 'interventions': [{'name': 'β-Palmitate Content', 'type': 'OTHER', 'armGroupLabels': ['Improved Infant Formula Group']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['General Infant Formula Group']}, {'name': 'β-Palmitate Content Naturely in Human Milk', 'type': 'OTHER', 'armGroupLabels': ['Human Milk Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fei Bei, Master', 'role': 'CONTACT', 'email': 'Fionabei@163.com', 'phone': '86-21-38625778'}], 'facility': "Shanghai Children's Medical Center", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Fei Bei, Master', 'role': 'CONTACT', 'email': 'Fionabei@163.com', 'phone': '86-21-38625778'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beingmate Baby & Child Food Co Ltd .', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}