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

Head :
Hercberg Serge, Unité de Recherche en Epidémiologie Nutritionnelle (UREN), U557 Inserm / U1125 Inra / Cnam / Université Paris 13 (Sorbonne Paris-Cité)
Galan Pilar, Unité de Recherche en EPidémiologie Nutritionnele (UREN), U557 Inserm / U1125 Inra / Cnam / Université Paris 13 (Sorbonne Paris-Cité)

Last update : 01/01/2020 | Version : 3 | ID : 3319

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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General
Identification
Detailed name SU.FOL.OM3 Trial: B-vitamins and N-3 polyunsaturated fatty acids supplementation and risk of recurrence of cardiovascular events
Sign or acronym SU.FOL.OM3
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation CCPPRB No 1933 -CNIL No 901230
General Aspects
Medical area Cardiology
Health determinants Nutrition
Social and psychosocial factors
Keywords cardiovascular diseases, cerebrovascular accident (CVA), randomized trial, secondary prevention
Scientific investigator(s) (Contact)
Name of the director Hercberg
Surname Serge
Address UFR SMBH, 74 rue Marcel Cachin, 93017 Bobigny
Phone + 33 (0)1 48 38 89 32
Email s.hercberg@uren.smbh.univ-paris13.fr
Unit Unité de Recherche en Epidémiologie Nutritionnelle (UREN), U557 Inserm / U1125 Inra / Cnam / Université Paris 13 (Sorbonne Paris-Cité)
Organization Inserm, INRA, CNAM
Name of the director Galan
Surname Pilar
Address UFR SMBH, 74 rue Marcel Cachin, 93017 Bobigny
Phone + 33 (0)1 48 38 89 32
Email p.galan@uren.smbh.univ-paris13.fr
Unit Unité de Recherche en EPidémiologie Nutritionnele (UREN), U557 Inserm / U1125 Inra / Cnam / Université Paris 13 (Sorbonne Paris-Cité)
Organization Inserm, INRA, CNAM
Collaborations
Participation in projects, networks and consortia Yes
Funding
Funding status Mixed
Details Inserm, Ministère de la Recherche, fondation coeurs et artères, Pierre Fabre, Danone, Candia, Eprova
Governance of the database
Sponsor(s) or organisation(s) responsible Inserm
Organisation status Public
Sponsor(s) or organisation(s) responsible INRA
Organisation status Public
Sponsor(s) or organisation(s) responsible CNAM
Organisation status Public
Sponsor(s) or organisation(s) responsible Université Paris XIII
Organisation status Public
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Cohort study
Database recruitment is carried out by an intermediary A selection of health care professionals
A selection of health institutions and services
Database recruitment is carried out as part of an interventional study Yes
Details Performed at group level (clusters)
Additional information regarding sample selection. Subject inclusion procedure: subjects are recruited through a national network of over 686 clinicians working in hospitals, privately or in cardiovascular rehabilitation centers; these cardiologists, neurologists or internists report to national SU.FOL.OM 3 coordinators all patients who meet the inclusion and exclusion criteria. Then, the patients are contacted by the SU.FOL.OM 3 trial physicians, who shall invite them for an appointment for their definitive inclusion in one of the 166 SU.FOL.OM 3 local centers. During this appointment, the subjects benefit from a blood test so as to determine different biological parameters and take anthropometric measurements; they shall also fill in a dietary questionnaire and receive B vitamins and/or omega 3 supplements in the form of soft capsules made specifically for the trial.Double blind randomized trial: the subjects included are randomly split into four groups, receiving either a combination of B vitamins: folates (in the form of 5-methyl-tetra-hydro-folates) (560 µg/day), vitamin B6 (3 mg/day) and vitamin B12 (20 µg/day) and an "omega 3" placebo, or omega 3 polyunsaturated fatty acids (600 mg/day, in the form of E.P.A./D.H.A. 2 :1) and a "B vitamins" placebo, or the combination of group B vitamins and omega 3 polyunsaturated fatty acids, or an "omega 3" placebo and "B vitamins" placebo.
Database objective
Main objective 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.
Inclusion criteria 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).

Exclusion criterion: 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.
Population type
Age Adulthood (45 to 64 years)
Elderly (65 to 79 years)
Population covered Sick population
Gender Male
Woman
Geography area National
Detail of the geography area France
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 09/2003
Date of last collection (YYYY or MM/YYYY) 01/2010
Size of the database
Size of the database (number of individuals) [1000-10 000[ individuals
Details of the number of individuals 2501
Data
Database activity Data collection completed
Type of data collected Clinical data
Declarative data
Biological data
Clinical data (detail) Medical registration
Details of collected clinical data Clinical examination upon inclusion and during follow-up (yearly)Information gathered during the clinical examination: blood pressure, clinical examination focused on the disease, anthropometry
Declarative data (detail) Paper self-questionnaire
Details of collected declarative data Clinical examination upon inclusion and during follow-up (yearly)Information gathered during the clinical examination: blood pressure, clinical examination focused on the disease, anthropometry
Biological data (detail) 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.
Presence of a biobank Yes
Contents of biobank Serum
Plasma
Blood cells isolated
DNA
Others
Details of biobank content serum bank, plasma bank, DNA bank, Buffy coat
Health parameters studied Health event/morbidity
Health event/mortality
Procedures
Data collection method 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
Quality procedure(s) used 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.
Participant monitoring Yes
Links to administrative sources No
Promotion and access
Promotion
Link to the document http://www.hal.inserm.fr/SUFOLOM3
Description List of publications in HAL
Link to the document http://www.ncbi.nlm.nih.gov/pubmed/?term=SU.FOL.OM3+OR+SU-FOL-OM3+OR+SUFOLOM3+OR+23352552[uid]+OR+24965307[uid]
Description List of publications in Pubmed
Link to the document http://www.hal.inserm.fr/SUFOLOM3
Link to the document http://www.ncbi.nlm.nih.gov/entrez/eutils/erss.cgi?rss_guid
Access
Terms of data access (charter for data provision, format of data, availability delay) Possible use of data by academic teams (contractual conditions)
Data cannot be used by manufacturers
Involvement in a cohort network: network of trials on intervention by folates (55 000 SJ au TAL)
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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