Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-02-20 @ 10:12 PM
Study NCT ID:
NCT01747668
Status:
COMPLETED
Last Update Posted:
2013-05-31
First Post:
2012-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lactation Fortification Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013024', 'term': 'Soybean Oil'}, {'id': 'D024502', 'term': 'alpha-Tocopherol'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D024505', 'term': 'Tocopherols'}, {'id': 'D014810', 'term': 'Vitamin E'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-30', 'studyFirstSubmitDate': '2012-12-10', 'studyFirstSubmitQcDate': '2012-12-11', 'lastUpdatePostDateStruct': {'date': '2013-05-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Blood levels of nutrients and fatty acids', 'timeFrame': '1 and 43 days', 'description': 'In mothers at 1 and 43 days In infants at 43 days'}], 'primaryOutcomes': [{'measure': 'Breast milk concentration of carotenoids', 'timeFrame': '1 - 43 days'}], 'secondaryOutcomes': [{'measure': 'Breast milk concentration of fatty acids', 'timeFrame': '1 - 43 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mother and Infant Pairs'], 'conditions': ['Lactation']}, 'referencesModule': {'references': [{'pmid': '24899160', 'type': 'DERIVED', 'citation': 'Sherry CL, Oliver JS, Renzi LM, Marriage BJ. Lutein supplementation increases breast milk and plasma lutein concentrations in lactating women and infant plasma concentrations but does not affect other carotenoids. J Nutr. 2014 Aug;144(8):1256-63. doi: 10.3945/jn.114.192914. Epub 2014 Jun 4.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the impact of nutrient supplementation during lactation on levels in breast milk.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nSubjects will be eligible for the study if they meet all of the following inclusion criteria:\n\n1. Mother with singleton birth, 37-42 weeks gestation and ≥ 2490g\n2. Pre-pregnancy BMI \\</= 30\n3. Mother is ≥ 18 years of age\n4. Mother is 4-6 weeks postpartum and has been successfully continuously lactating\n5. Mother agrees to abstain from the use of any Docosahexaenoic acid (DHA), lutein and/or vitamin E containing supplements for at least 10 days prior to providing a baseline breast milk sample\n6. Mother agrees to abstain from the use of non-study supplements throughout the study\n7. Mother plans to continue breastfeeding for at least 6 weeks from the start of the study\n8. No significant ongoing medical problems in the infant as determined from infant's medical history as related by the parent(s) to the enrolling center personnel\n\nExclusion Criteria:\n\nSubjects will be excluded from the study if they meet any of the following criteria:\n\n1. Subject had adverse maternal and/or fetal medical history\n2. Subject is participating in a non-Abbott approved concomitant trial\n3. Mother is taking cholesterol medication and/or medication affecting lipid absorption and/or transport"}, 'identificationModule': {'nctId': 'NCT01747668', 'briefTitle': 'Lactation Fortification Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Nutrition'}, 'officialTitle': 'Impact of Nutrient Supplementation on Breast Milk Levels of Lactating Women', 'orgStudyIdInfo': {'id': 'AL05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Supplement', 'description': 'soft-gel placebo capsules, 2 capsules from the placebo bottle per day', 'interventionNames': ['Dietary Supplement: Placebo (soybean oil and dl-alpha-tocopheryl acetate)']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Supplement A', 'description': 'soft-gel capsules; 1 capsule from the experimental bottle and 1 capsule from the placebo bottle per day', 'interventionNames': ['Dietary Supplement: Similac Prenatal Vitamin soft-gel capsule', 'Dietary Supplement: Placebo (soybean oil and dl-alpha-tocopheryl acetate)']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Supplement B', 'description': 'soft-gel capsules; 2 capsules from the experimental bottle per day', 'interventionNames': ['Dietary Supplement: Similac Prenatal Vitamin soft-gel capsule']}], 'interventions': [{'name': 'Similac Prenatal Vitamin soft-gel capsule', 'type': 'DIETARY_SUPPLEMENT', 'description': 'One capsule per day for Experimental Supplement A Group; Two capsules per day for Experimental Supplement B Group', 'armGroupLabels': ['Experimental Supplement A', 'Experimental Supplement B']}, {'name': 'Placebo (soybean oil and dl-alpha-tocopheryl acetate)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Two capsules per day for the Placebo Group; One capsule per day for the Experimental Group A', 'armGroupLabels': ['Control Supplement', 'Experimental Supplement A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46256', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Northpoint Pediatrics, LLC', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '45414', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Pediatric Research Association, Inc', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '45420', 'city': 'Kettering', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Pediatric Research Association, Inc', 'geoPoint': {'lat': 39.6895, 'lon': -84.16883}}, {'zip': '44124', 'city': 'Mayfield Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Institute of Clinical Research', 'geoPoint': {'lat': 41.51922, 'lon': -81.4579}}, {'zip': '44129', 'city': 'Parma', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Cleveland Pediatric Research Center, LLC', 'geoPoint': {'lat': 41.40477, 'lon': -81.72291}}, {'zip': '44145', 'city': 'Westlake', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Cleveland Pediatric Research Center, LLC', 'geoPoint': {'lat': 41.45532, 'lon': -81.91792}}], 'overallOfficials': [{'name': 'Christina Sherry, PhD, RD', 'role': 'STUDY_CHAIR', 'affiliation': 'Abbott Nutrition'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}