Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-25 @ 5:25 PM
Study NCT ID:
NCT01123759
Status:
COMPLETED
Last Update Posted:
2010-05-14
First Post:
2010-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healthful Seafood Consumption for Sensitive Populations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-13', 'studyFirstSubmitDate': '2010-05-12', 'studyFirstSubmitQcDate': '2010-05-13', 'lastUpdatePostDateStruct': {'date': '2010-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hair Mercury', 'timeFrame': '3 months', 'description': 'The hair mercury after feeding low mercury fish for 3 months'}], 'secondaryOutcomes': [{'measure': 'Blood mercury concentration', 'timeFrame': '3 months', 'description': 'The blood mercury concentration after feeding low mercury fish for 3 months'}, {'measure': 'Blood omega-3 fatty acid concentrations', 'timeFrame': '3 months', 'description': 'Blood omega-3 fatty acid concentration after feeding either salmon or tilapia for 3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fish', 'mercury', 'omega-3 fatty acids', 'infant', 'brain development', 'pregnancy', 'nursing mother', 'dietary recommendations', 'Hair mercury', 'Blood mercury', 'Recommendations for pregnant or nursing women', 'Infant brain health'], 'conditions': ['Infant Brain Health']}, 'descriptionModule': {'briefSummary': 'Fish can provide pregnant women with omega-3 fatty acids for fetal brain development but some fish contains high levels of mercury which is detrimental to fetal brain development. The hypothesis is that women who have previously consumed high mercury fish can reduce the mercury level in their bodies and improve their omega-3 levels in three months by eating fish that is high in omega-3 fatty acids and low in mercury.', 'detailedDescription': "Exposure to methylmercury, a developmental toxicant found primarily in fish. Fish is nutritionally important for providing long chain omega-3 fatty acids that are important for perinatal health. Since maternal transfer of mercury and omega-3 fatty acids are the primary routes for fetal (placental transfer) or infant (maternal milk) exposure, there is a critical need to develop specific advice for childbearing-aged women based upon the 2004 Dietary Guidelines Advisory Committee's recommended intake i.e., consume 8 ounces of fish per week. This clinical trial investigates whether weekly consumption of selected fish species for 12 weeks can improve plasma concentrations of the omega-3 fatty acids (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) while reducing hair or blood mercury concentrations."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hair mercury levels equal to or greater than 0.8 ppm\n\nExclusion Criteria:\n\n* Pregnant or planning to become pregnant in the next 3 months\n* Nursing'}, 'identificationModule': {'nctId': 'NCT01123759', 'briefTitle': 'Healthful Seafood Consumption for Sensitive Populations', 'organization': {'class': 'OTHER', 'fullName': 'Purdue University'}, 'officialTitle': 'Consuming Fish to Reduce Mercury Intake While Optimizing Omega-3 Fatty Acid Status', 'orgStudyIdInfo': {'id': 'USDA-CSREES 07-5110-03804'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tilapia', 'description': 'Subjects are fed 6 oz tilapia once a week for 3 months', 'interventionNames': ['Other: Feeding low mercury fish']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Salmon', 'description': 'Subjects fed 6 oz salmon once a week for 3 months', 'interventionNames': ['Other: Feeding low mercury fish']}], 'interventions': [{'name': 'Feeding low mercury fish', 'type': 'OTHER', 'description': 'Subjects fed 6 oz of either tilapia (low omega-3 fish) or salmon (high omega-3 fish) for 3 months. Both fish are low in mercury', 'armGroupLabels': ['Salmon', 'Tilapia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32307-4100', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida A&M University', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '47907-2059', 'city': 'West Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'Purdue University, Department of Foods and Nutrition', 'geoPoint': {'lat': 40.42587, 'lon': -86.90807}}], 'overallOfficials': [{'name': 'Charles Santerre, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Purdue University, Department of Foods and Nutrition'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Purdue University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Florida A&M University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Charles Santerre, Professor', 'oldOrganization': 'Purdue University, Dept of Foods and Nutrition'}}}}