Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:28 PM
Study NCT ID:
NCT01174134
Status:
COMPLETED
Last Update Posted:
2011-09-02
First Post:
2010-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Study Products Containing Varying Quantities of Docosahexaenoic Acid (DHA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'lastUpdateSubmitDate': '2011-08-31', 'studyFirstSubmitDate': '2010-07-30', 'studyFirstSubmitQcDate': '2010-08-02', 'lastUpdatePostDateStruct': {'date': '2011-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood lipid levels of Docosahexaenoic Acid (DHA) at enrollment and after two months, assessment of usual DHA intake, and product acceptability and use'}], 'secondaryOutcomes': [{'measure': 'Growth'}, {'measure': 'Determination of nutrient status, including iron and vitamin D status'}, {'measure': 'Adverse Events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Levels of DHA in the Blood']}, 'descriptionModule': {'briefSummary': 'The clinical trial will provide a milk-based drink with constant amounts of nutrients but differing amount of Docosahexaenoic Acid (DHA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '18 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant is 18 to 36 months of age\n* Participant's current weight and height within the 10th to 90th percentiles\n* Parent/caregiver reports that participant consumes milk or a milk-based beverage on a daily basis\n* Participant lives at home with parent(s) or other family member(s)\n* Signed informed consent and authorization obtained to use and or disclose Protected Health Information (PHI)\n\nExclusion Criteria:\n\n* Participant who is receiving any breast milk at time of randomization\n* Participant with an active infection.\n* Participant with a history of underlying disease, chronic disease, or congenital malformation which in the opinion of the Investigator is likely to interfere with the evaluation of the participant.\n* Known or suspected intolerance to cow's milk protein\n* Participant diagnosed with diabetes\n* Participant is from a multiple birth and the sibling(s) are still living\n* Participant with a sibling that has participated in this study."}, 'identificationModule': {'nctId': 'NCT01174134', 'briefTitle': 'The Effects of Study Products Containing Varying Quantities of Docosahexaenoic Acid (DHA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mead Johnson Nutrition'}, 'orgStudyIdInfo': {'id': '3375-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Milk-based beverage w/out DHA', 'interventionNames': ['Other: Nutritional beverage']}, {'type': 'EXPERIMENTAL', 'label': 'Milk-based beverage with DHA', 'interventionNames': ['Other: Nutritional beverage']}, {'type': 'EXPERIMENTAL', 'label': 'Milk-based beverage containing DHA at a higher level', 'interventionNames': ['Other: Nutritional beverage']}], 'interventions': [{'name': 'Nutritional beverage', 'type': 'OTHER', 'armGroupLabels': ['Milk-based beverage containing DHA at a higher level', 'Milk-based beverage w/out DHA', 'Milk-based beverage with DHA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Susan Carlson, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mead Johnson Nutrition', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Carol Berseth, M.D.', 'oldOrganization': 'Mead Johnson Nutrition'}}}}