ITMO public health
Last update : 01/01/2020 | Version : 3 | ID : 3319
| 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 |
| 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 |
| 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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