{"doc_desc":{"title":"Antioxidant Vitamins and Mineral supplementation","idno":"FRESH-PEF3925-en","producers":[{"name":"Serge HERCBERG","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3925-en","IDno":{"metadata_no":[{"agency":"PEF","code":"3925"},{"agency":"FReSH","code":"FRESH-PEF3925"}]},"title":"Antioxidant Vitamins and Mineral supplementation","alternate_title":"SU.VI.MAX"},"study_authorization":{"agency":[]},"authoring_entity":[{"name":"Serge;HERCBERG","firstname":"Serge","lastname":"HERCBERG","type":"investigator","extlink":[{"title":"ORCID","uri":"0000-0002-3168-1350","role":"pi id"},{"title":"IdRef","uri":"02858709X","role":"pi id"},{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"RNSR","uri":"201119719R","role":"labo id"}],"email":"dir@impact.tn","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","PILabo":"INSERM \/ Unit\u00e9 de Recherche en Epid\u00e9miologie Nutritionnelle (UREN), U557 Inserm \/ U1125 Inra \/ Cnam \/ Universit\u00e9 Paris 13 (Sorbonne Paris-Cit\u00e9)","isContact":true}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"CATALENT PHARMA SOLUTIONS, LLC","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04brn0b16","role":"sponsor id"},{"title":"SIREN","uri":"981349574","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":"Serge;HERCBERG","lastname":"HERCBERG","firstname":"Serge","type":"contact","email":"dir@impact.tn","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id","title":"ROR"},{"uri":"180036048","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"prevention."},{"keyword":"Health events"},{"keyword":"death"}],"topics":[{"topic":"Oncology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/5784b7f1-c7ce-49d9-9f38-aebcda0ff41d"},{"title":"MeSH","uri":"D008495"}]},{"topic":"Behavioral determinants: Eating habits","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"}],"purpose":"Establish the causal nature of the link between antioxidant nutrients and risk of cancer, ischemic heart diseases or mortality. Better know the relations between nutrition and health, creating a large data bank on French people food consumption and health condition.","abstract":"","coll_dates":[{"start":"1994-01-01","end":"2003-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\"level_sex_clusion_I\":[{\"value\":\"Male\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008297\"}},{\"value\":\"Female\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D005260\"}}],\"level_age_clusion_I\":[{\"value\":\"Young Adult (19 to 24 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D055815\"}},{\"value\":\"Adult (25 to 44 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000328\"}},{\"value\":\"Middle Aged (45 to 64 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D008875\"}},{\"value\":\"Aged (65 to 79 years)\",\"concept\":{\"vocab\":\"MeSH\",\"vocabURI\":\"D000368\"}}],\"level_type_clusion_I\":\"General population\",\"level_type_clusion_other\":\"\",\"clusion_I\":\"Men between 45 and 60 years old and women between 35 and 60 years old.\",\"clusion_E\":\"\"}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Paraclinical data (non-biological) : Imaging']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Population database for statistical purposes']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}","{\"concept\":{\"vocabURI\":\"Recording\",\"vocab\":\"CESSDA\"},\"value\":\"Recording (audio, video, electrophysiological, imaging)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[10000-20000[ individuals","response_rate":"12741 subjects included, 12177 subjects still alive in 2003"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}","notes":""},"dataset_use":{"restrictions":"Possible data utilization for other researches. Evaluation of the pertinence of the project, of its financing and its feasibility. Establishment of a convention for the industrials.","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""}}},"additional":{"versionLang":"en","originLang":"en","autoTranslation":false,"status":"Imported","creationDate":"17-12-2013","lastUpdatedManual":"31-12-2013","contributorName":"Serge HERCBERG","contributorAffiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"Liste des publications dans HAL","link":"http:\/\/www.hal.inserm.fr\/SUVIMAX"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Industry"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"- Health self-questionnaire (annual): all health events, medical care consumption, observance and morbidity have been collected, health status SF-36 scale. - Food self-questionnaire (6 times a year): qualitative and quantitative food registration, places of food consumption, quantities consumed, methods of preparation, food origin, brands, useful information in order to precisely evaluate the nutritional intake of the volunteers. - Food frequency self-questionnaire: general food habitudes, half-qualitative. - Physical activity self-questionnaire. - Clinical data collection (at inclusion, then every 2 years): complete clinical examination, ECG, TA, pap smear ( women who didn't had it during the year), fecal occult blood test (SJ superior to 45 years), visual acuity mensuration, anthropometric measures, mammography (women older than 50) Self questionnaire: direct data entry Clinical examinations: manual double data entry Biological examinations: direct data entry","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Blood, faeces, urine","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}