Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT03155659
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2017-05-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fish, Polyunsaturated Fatty Acids Intake and Mortality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50145}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1989-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-12', 'studyFirstSubmitDate': '2017-05-13', 'studyFirstSubmitQcDate': '2017-05-13', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Mortality', 'timeFrame': 'From baseline until death or censoring on 31 December 2011, whichever came first, assessed up to an average of 10 years', 'description': 'Total Mortality from All Causes'}], 'secondaryOutcomes': [{'measure': 'Cause-specific mortality', 'timeFrame': 'From baseline until death or censoring on 31 December 2011, whichever came first, assessed up to an average of 10 years', 'description': 'Cause-specific mortality from diseases'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fish', 'Polyunsaturated fatty acids', 'Mortality', 'CHNS', 'NHANES'], 'conditions': ['Polyunsaturated Fatty Acids', 'Mortality']}, 'referencesModule': {'references': [{'pmid': '25969396', 'type': 'RESULT', 'citation': 'Zhao LG, Sun JW, Yang Y, Ma X, Wang YY, Xiang YB. Fish consumption and all-cause mortality: a meta-analysis of cohort studies. Eur J Clin Nutr. 2016 Feb;70(2):155-61. doi: 10.1038/ejcn.2015.72. Epub 2015 May 13.'}, {'pmid': '22968891', 'type': 'RESULT', 'citation': 'Rizos EC, Ntzani EE, Bika E, Kostapanos MS, Elisaf MS. Association between omega-3 fatty acid supplementation and risk of major cardiovascular disease events: a systematic review and meta-analysis. JAMA. 2012 Sep 12;308(10):1024-33. doi: 10.1001/2012.jama.11374.'}, {'pmid': '29551407', 'type': 'DERIVED', 'citation': 'Zhuang P, Wang W, Wang J, Zhang Y, Jiao J. Polyunsaturated fatty acids intake, omega-6/omega-3 ratio and mortality: Findings from two independent nationwide cohorts. Clin Nutr. 2019 Apr;38(2):848-855. doi: 10.1016/j.clnu.2018.02.019. Epub 2018 Mar 3.'}], 'seeAlsoLinks': [{'url': 'http://dx.doi.org/10.1038/ejcn.2015.72', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Data linking fish, polyunsaturated fatty acids intake and mortality are lacking and conflicting. We aim to use data from the China Health and Nutrition Survey (CHNS) and National Health and Nutrition Examination Survey (NHANES) to investigate the associations of fish and polyunsaturated fatty acids (PUFA) intake with mortality in Chinese and US populations. The study findings will be informative for addressing the role of fish and specific PUFA in human health and improve basis for dietary recommendations.', 'detailedDescription': 'Data from the China Health and Nutrition Survey (CHNS, from 1989 to 2011) and National Health and Nutrition Examination Survey (NHANES), including NHANES III conducted in 1988-1994 and continuous NHANES 1999-2010 were used to investigate the associations of fish and polyunsaturated fatty acids intake with mortality.The following variables were used:\n\n1. Demographics: age, sex, race/ethnicity, residence\n2. Socioeconomic variables: education, marital status,\n3. Dietary variables: Intakes of fish, polyunsaturated fatty acids, total energy, vegetables, fruits, red meat and saturated fat\n4. Clinical assessments: hypertension, diabetes, cancer, cardiovascular disease (CVD), family history of CVD'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'CHNS is an ongoing, large-scale, household-based cohort starting in 1989. The survey used a multi-stage, random cluster process to draw a sample of 9 provinces and municipal cities, which take up about half of Chinese population. NHANES is also a nationally-representative study of nutrition and health for individuals residing in the U.S. Our study included participants in CHNS and NHANES who met the eligibility criteria.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged ≥20 with complete data on diet and follow-up time\n\nExclusion Criteria:\n\n* Missing information for mortality\n* Cardiovascular disease\n* Cancer'}, 'identificationModule': {'nctId': 'NCT03155659', 'briefTitle': 'Fish, Polyunsaturated Fatty Acids Intake and Mortality', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Fish, Polyunsaturated Fatty Acids Intake and Mortality: Analysis of CHNS and NHANES', 'orgStudyIdInfo': {'id': 'Cohort_PUFA'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Health and Nutrition', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jingjing Jiao', 'investigatorAffiliation': 'Zhejiang University'}}}}