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SU.FOL.OM3 Trial: B-vitamins and N-3 polyunsaturated fatty acids supplementation and risk of recurrence of cardiovascular events

France, 2003 - 2010
Reference ID
FRESH-PEF3319-en
Producer(s)
Pilar;GALAN, Serge;HERCBERG
Metadata
DDI/XML JSON
Study website Interactive tools
Created on
Feb 18, 2026
Last modified
Feb 18, 2026
Page views
40
  • Identification
  • Scope
  • Coverage
  • Producers and sponsors
  • Study authorization
  • Sampling
  • Survey instrument
  • Data collection
  • Study activities
  • Quality standards
  • Data Access
  • Contacts

    • Identification

    Survey ID number

    FRESH-PEF3319-en
    Title

    SU.FOL.OM3 Trial: B-vitamins and N-3 polyunsaturated fatty acids supplementation and risk of recurrence of cardiovascular events
    Abbreviation or Acronym

    SU.FOL.OM3
    Country
    Name Country code
    France fr
    Kind of Data

    ['Clinical data','Biological data','Participant-reported health data']
    Unit of Analysis

    Individuals

    Scope

    Topics
    Topic Vocabulary
    Cardiology and vascular medicine health theme
    Ischaemic heart diseases cim-11
    Diseases of the circulatory system cim-11
    Socio-demographic and economic determinants health determinant
    Behavioral determinants: Eating habits health determinant
    Healthcare system determinants: Use of care health determinant
    Behavioral determinants health determinant
    Healthcare system determinants health determinant
    Keywords
    cardiovascular diseases cerebrovascular accident (CVA) randomized trial secondary prevention

    Coverage

    Universe

    {"level_sex_clusion_I":[{"value":"Male","concept":{"vocab":"MeSH","vocabURI":"D008297"}},{"value":"Female","concept":{"vocab":"MeSH","vocabURI":"D005260"}}],"level_age_clusion_I":[{"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":"Patients population","level_type_clusion_other":"","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). ","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."}

    Producers and sponsors

    Primary investigators
    Name
    Pilar;GALAN
    Serge;HERCBERG
    Producers
    Name Role
    INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM) sponsor
    INSTITUT NATIONAL DE RECHERCHE POUR L'AGRICULTURE L'ALIMENTATION ET L'ENVIRONNEMENT (INRAE) sponsor
    UNIVERSITE SORBONNE PARIS NORD sponsor
    CONSERVATOIRE NATIONAL DES ARTS ET METIERS (CNAM) sponsor
    Funding Agency/Sponsor
    Name
    CANDIA (C.SAS)
    DANONE
    INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)
    MERCK SANTE
    MINISTERE DE L’ENSEIGNEMENT SUPERIEUR, DE LA RECHERCHE ET DE L’ESPACE
    PIERRE FABRE (FRANCE)

    Study authorization

    Agency
    Agency name
    CNIL
    CPP

    Sampling

    Sample frame

    Unit Type

    ['Through organizations (health services or institutions, schools, businesses, etc.)','Through independent healthcare practitioners']
    Sampling Procedure

    ['{"concept":{"vocabURI":"Other","vocab":"CESSDA"},"value":"Other"}']

    Survey instrument

    Questionnaires

    Access on specific project only
    Methodology notes

    Observational Study

    Data collection

    Dates of Data Collection
    Start End
    2003-01-01 2010-01-01
    Mode of data collection
    • {"concept":{"vocabURI":"SelfAdministeredQuestionnaire","vocab":"CESSDA"},"value":"Self-administered questionnaire"}
    • {"concept":{"vocabURI":"Interview","vocab":"CESSDA"},"value":"Interview with the participant (including clinical)"}

    Study activities

    Study activities
    Type
    primary evaluation
    Description
    Health event/morbidity Health event/mortality

    Quality standards

    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.']

    Data Access

    Access conditions

    Involvement in a cohort network: network of trials on intervention by folates (55 000 SJ au TAL)
    Availability Status

    {"value":"Restricted access","extLink":[{"title":"COAR","uri":"http://purl.org/coar/access_right/c_16ec"}]}
    Restrictions

    Possible use of data by academic teams (contractual conditions) Data cannot be used by manufacturers

    Contacts

    Contacts
    Name Email
    Pilar;GALAN p.galan@eren.smbh.univ-paris13.fr
    Serge;HERCBERG s.hercberg@eren.smbh.univ-paris13.fr
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