{"doc_desc":{"title":"SU.FOL.OM3 Trial: B-vitamins and N-3 polyunsaturated fatty acids supplementation and risk of recurrence of cardiovascular events","idno":"FRESH-PEF3319-en","producers":[{"name":"Serge HERCBERG","affiliation":"UNIVERSITE SORBONNE PARIS NORD"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3319-en","IDno":{"metadata_no":[{"agency":"PEF","code":"3319"},{"agency":"FReSH","code":"FRESH-PEF3319"}]},"title":"SU.FOL.OM3 Trial: B-vitamins and N-3 polyunsaturated fatty acids supplementation and risk of recurrence of cardiovascular events","alternate_title":"SU.FOL.OM3"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Pilar;GALAN","PILabo":"Inserm, INRA, CNAM, universit\u00e9 Paris 13 \/ Equipe de Recherche en Epid\u00e9miologie Nutritionnele (EREN), U1153 Inserm \/ U1125 Inra \/ Cnam \/ Universit\u00e9 Paris 13 (Sorbonne Paris-Cit\u00e9)","affiliationName":"UNIVERSITE SORBONNE PARIS NORD","extlink":[{"title":"","uri":"","role":"pi 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(PEF)","producers":[{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"sponsor id"},{"title":"SIREN","uri":"180036048","role":"sponsor id"}],"role":"sponsor"},{"name":"INSTITUT NATIONAL DE RECHERCHE POUR L'AGRICULTURE L'ALIMENTATION ET L'ENVIRONNEMENT (INRAE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/003vg9w96","role":"sponsor id"},{"title":"SIREN","uri":"180070039","role":"sponsor id"}],"role":"sponsor"},{"name":"UNIVERSITE SORBONNE PARIS NORD","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0199hds37","role":"sponsor id"},{"title":"SIREN","uri":"199312380","role":"sponsor id"}],"role":"sponsor"},{"name":"CONSERVATOIRE NATIONAL DES ARTS ET METIERS (CNAM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0175hh227","role":"sponsor id"},{"title":"SIREN","uri":"197534713","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"CANDIA (C.SAS)","extlink":[{"title":"SIREN","uri":"352014955"}]},{"name":"DANONE","extlink":[]},{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]},{"name":"MERCK SANTE","extlink":[{"title":"SIREN","uri":"572028033"}]},{"name":"MINISTERE DE L\u2019ENSEIGNEMENT SUPERIEUR, DE LA RECHERCHE ET DE L\u2019ESPACE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03sjk9a61"},{"title":"SIREN","uri":"110044013"}]},{"name":"PIERRE FABRE (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04hdhz511"}]},{"name":"","extlink":[]}]},"distribution_statement":{"contact":[{"name":"Pilar;GALAN","email":"p.galan@eren.smbh.univ-paris13.fr","type":"contact","affiliationName":"UNIVERSITE SORBONNE PARIS NORD","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/0199hds37","role":"organisation id","title":"ROR"},{"uri":"199312380","role":"organisation id","title":"SIREN"}]},{"name":"Serge;HERCBERG","email":"s.hercberg@eren.smbh.univ-paris13.fr","type":"contact","affiliationName":"UNIVERSITE SORBONNE PARIS NORD","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/0199hds37","role":"organisation id","title":"ROR"},{"uri":"199312380","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"cardiovascular diseases"},{"keyword":"cerebrovascular accident (CVA)"},{"keyword":"randomized trial"},{"keyword":"secondary prevention"}],"topics":[{"topic":"Cardiology and vascular medicine","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/4455c187-2f2f-4cd1-a4dd-449f59d73b39"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/c42fc6ec-b216-4a24-9e9d-f5e781c175a0"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D002309"}]},{"topic":"Ischaemic heart diseases","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1964269418","title":"CIM-11"}]},{"topic":"Diseases of the circulatory system","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/426429380","title":"CIM-11"}]},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"},{"topic":"Behavioral determinants: Eating habits","vocab":"health determinant"},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"Primary objectives: check the impact of folate (and vitamin B6 or B12) and\/or omega 3 supplements in preventing the recurrence of ischemic disorders in patients with a background of ischemic cardio or cerebrovascular history. Secondary objective: assess the role of certain genetic mutations in the ability of supplements to reduce the risk of cardiovascular diseases.","abstract":"","coll_dates":[{"start":"2003-01-01","end":"2010-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Subjects aged between 45 and 80, having presented a myocardial infarction, unstable angina or stroke in the period preceding their inclusion (event occurred at least one month and at the most one year prior to inclusion).  \",\n    \"clusion_E\": \"subjects that have to take B12, folic acid or B6 supplements, subjects under methotrexate treatment, subjects suffering from a life-threatening non-cardiovascular disease over the 5 years of the study, severe chronic kidney disease sufferers.\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Coherency query during and after entry of computer data.Management of missing data by return to source file or return to patient.Reminders sent out to physicians for follow-up appointments.Reminders sent out to subjects for follow-up appointments.Internal quality audit performedThe patients are informed of what use will be made of their data.']"}},"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":"['Through independent healthcare practitioners Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"2501"},"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\"}]}"},"dataset_use":{"restrictions":"Possible use of data by academic teams (contractual conditions) Data cannot be used by manufacturers","conditions":"Involvement in a cohort network: network of trials on intervention by folates (55 000 SJ au TAL)","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"30-03-2012","lastUpdatedAuto":null,"lastUpdatedManual":"01-01-2020","isContributorPI":"No","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\/SUFOLOM3"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industry","Industry","Public (France)","Industry","Public (France)","Industry","Private non-profit"],"otherFundingAgentType":["","","","","","",""]},"sponsor":{"sponsorType":["Public (France)","Public (France)","Public (France)","Public (France)"],"otherSponsorType":["","","",""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"The subjects benefit from annual clinico-biological follow-up from the technicians and physicians in the SU.FOL.OM 3 team. All events concerning the health of the subjects (changes in treatment, hospitalization, surgery, recurrences, death, etc.) are gathered at annual appointments in the SU.FOL.OM 3 local centers or through bi-annual questionnaires; additional information is also obtained through bi-annual questionnaires; and from GPs or consultants who care for the patients.Data collected by:- self-questionnaire: (1) health events, progression in certain risk factors and lifestyle habits, (2) dietary questionnaire.- clinical examination: blood pressure, clinical examination focused on the disease, anthropometry- information provided by a third party on cardiovascular or neurovascular health events occurring","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"Clinical examination upon inclusion and during follow-up (yearly)Information gathered during the clinical examination: blood pressure, clinical examination focused on the disease, anthropometry","biologicalDataDetails":"Blood: plasma homocysteine levels, plasma vitamin B12 levels, plasma pyridoxal phosphate levels, plasma and erythrocyte folate levels, genetic polymorphism of the gene coding for MTHFR, lipid count and blood glucose levels.","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}