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<docDscr>
  <citation>
    <titlStmt>
      <titl>SU.FOL.OM3 Trial: B-vitamins and N-3 polyunsaturated fatty acids supplementation and risk of recurrence of cardiovascular events</titl>
      <IDNo>FRESH-PEF3319-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="UNIVERSITE SORBONNE PARIS NORD" role="">Serge HERCBERG</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                SU.FOL.OM3 Trial: B-vitamins and N-3 polyunsaturated fatty acids supplementation and risk of recurrence of cardiovascular events            </titl>
      <altTitl>
                    SU.FOL.OM3                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF3319-en            </IDNo>
      <IDNo agency="PEF">
                    3319                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF3319                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Pilar GALAN                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="UNIVERSITE SORBONNE PARIS NORD">
        <ExtLink title="ROR" URI="https://ror.org/0199hds37" role="organisation id"/>
        <ExtLink title="SIREN" URI="199312380" role="organisation id"/>
      </AuthEnty>
      <AuthEnty>
                    Serge HERCBERG                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="UNIVERSITE SORBONNE PARIS NORD">
        <ExtLink title="ROR" URI="https://ror.org/0199hds37" role="organisation id"/>
        <ExtLink title="SIREN" URI="199312380" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)                    
                                    </producer>
      <producer role="sponsor">
                                            INSTITUT NATIONAL DE RECHERCHE POUR L&amp;#039;AGRICULTURE L&amp;#039;ALIMENTATION ET L&amp;#039;ENVIRONNEMENT (INRAE)                    
                                    </producer>
      <producer role="sponsor">
                                            UNIVERSITE SORBONNE PARIS NORD                    
                                    </producer>
      <producer role="sponsor">
                                            CONSERVATOIRE NATIONAL DES ARTS ET METIERS (CNAM)                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            CANDIA (C.SAS)                    
                                    </fundAg>
      <fundAg>
                                            DANONE                    
                                    </fundAg>
      <fundAg>
                                            INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)                    
                                    </fundAg>
      <fundAg>
                                            MERCK SANTE                    
                                    </fundAg>
      <fundAg>
                                            MINISTERE DE L’ENSEIGNEMENT SUPERIEUR, DE LA RECHERCHE ET DE L’ESPACE                    
                                    </fundAg>
      <fundAg>
                                            PIERRE FABRE (FRANCE)                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="UNIVERSITE SORBONNE PARIS NORD" email="p.galan@eren.smbh.univ-paris13.fr">
                    Pilar;GALAN
                                            <ExtLink title="ROR" URI="https://ror.org/0199hds37" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="199312380" role="organisation id"/>
                                    </contact>
      <contact affiliation="UNIVERSITE SORBONNE PARIS NORD" email="s.hercberg@eren.smbh.univ-paris13.fr">
                    Serge;HERCBERG
                                            <ExtLink title="ROR" URI="https://ror.org/0199hds37" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="199312380" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-16"/>
      <distDate date="2026-06-16"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    cardiovascular diseases</keyword>
      <keyword vocab="" vocabURI="">
                    cerebrovascular accident (CVA)</keyword>
      <keyword vocab="" vocabURI="">
                    randomized trial</keyword>
      <keyword vocab="" vocabURI="">
                    secondary prevention</keyword>
      <topcClas vocab="health theme">
                        Cardiology and vascular medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/4455c187-2f2f-4cd1-a4dd-449f59d73b39"/>
                                                            <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/c42fc6ec-b216-4a24-9e9d-f5e781c175a0"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D002309"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Ischaemic heart diseases                                            </topcClas>
      <topcClas vocab="cim-11">
                        Diseases of the circulatory system                                            </topcClas>
      <topcClas vocab="health determinant">
                        Socio-demographic and economic determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants: Eating habits                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Behavioral determinants                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
    </subject>
    <abstract contentType="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>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2003-01-01"/>
      <collDate event="end" date="2010-01-01"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe 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).                      </universe>
      <universe 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.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
      <dataKind>Biological data</dataKind>
    </sumDscr>
    <qualityStatement>
      <otherQualityStatement>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.</otherQualityStatement>
    </qualityStatement>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/morbidity
Health event/mortality</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through independent healthcare practitioners Through organizations (health services or institutions</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>schools</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>businesses</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.)</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>[1000-10000[ individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Self-administered questionnaire                                                            <concept vocab="CESSDA" vocabURI="SelfAdministeredQuestionnaire"/>
                                                    </collMode>
      <collMode>Interview with the participant (including clinical)                                                            <concept vocab="CESSDA" vocabURI="Interview"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <notes subject="observational study method">
                        Cohort study                    </notes>
    <anlyInfo>
      <respRate>2501</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            Restricted access                                                    </avlStatus>
    </setAvail>
    <useStmt>
      <restrctn>Possible use of data by academic teams (contractual conditions) Data cannot be used by manufacturers</restrctn>
      <conditions>Involvement in a cohort network: network of trials on intervention by folates (55 000 SJ au TAL)</conditions>
    </useStmt>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
