ITMO public health
Last update : 05/12/2015 | Version : 4 | ID : 3925
| General | |
| Identification | |
| Detailed name | Antioxidant Vitamins and Mineral supplementation |
| Sign or acronym | SU.VI.MAX |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL n° 334641 du 15/09/1994, CCPPRB n° 706 (Paris-Cochin) |
| General Aspects | |
| Medical area |
Cancer research |
| Health determinants |
Nutrition |
| Keywords | prevention., Health events, death |
| Scientific investigator(s) (Contact) | |
| Name of the director | Hercberg |
| Surname | Serge |
| Address | 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 |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Funding | |
| Funding status |
Mixed |
| Details | Inserm, INRA, CNAM, Fruit d'or recherche, Lipton, UBF, Candia, Kellog's, CERIN, Lu/Danone, Sodexho, Ceral, L'Oreal, Estee Lauder, Peugeot, Jet service, RP Scherer, France telecom, Becton Dickinson, Fould Springer, Boehringer Diagnostic, Seppic Givaudan, Lavirotte, Le grand canal, air liquide, carboxyque, klocke, Trophy radio, Jouan, Perkin Elmer |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Société RP Scherer (Catalent) |
| 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 population file |
| Database recruitment is carried out as part of an interventional study |
Yes |
| Details |
Performed at group level (clusters) |
| Additional information regarding sample selection. | Prospective. End of inclusions; 01/06/1995 |
| Database objective | |
| Main objective | Establish the causal nature of the link between antioxidant nutrients and risk of cancer, ischemic heart diseases or mortality. Better know the relations between nutrition and health, creating a large data bank on French people food consumption and health condition. |
| Inclusion criteria | Men between 45 and 60 years old and women between 35 and 60 years old. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) |
| Population covered |
General population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 10/1994 |
| Date of last collection (YYYY or MM/YYYY) | 01/2003 |
| Size of the database | |
| Size of the database (number of individuals) |
[10 000-20 000[ individuals |
| Details of the number of individuals | 12741 subjects included, 12177 subjects still alive in 2003 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
| Clinical data (detail) |
Medical registration |
| Declarative data (detail) |
Paper self-questionnaire |
| Paraclinical data (detail) | Imaging |
| Biological data (detail) | Blood, faeces, urine |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum Plasma DNA Others |
| Details of biobank content | Serum bank, plasma bank, DNA bank, couche leucocytaire |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | - Health self-questionnaire (annual): all health events, medical care consumption, observance and morbidity have been collected, health status SF-36 scale. - Food self-questionnaire (6 times a year): qualitative and quantitative food registration, places of food consumption, quantities consumed, methods of preparation, food origin, brands, useful information in order to precisely evaluate the nutritional intake of the volunteers. - Food frequency self-questionnaire: general food habitudes, half-qualitative. - Physical activity self-questionnaire. - Clinical data collection (at inclusion, then every 2 years): complete clinical examination, ECG, TA, pap smear ( women who didn't had it during the year), fecal occult blood test (SJ superior to 45 years), visual acuity mensuration, anthropometric measures, mammography (women older than 50) Self questionnaire: direct data entry Clinical examinations: manual double data entry Biological examinations: direct data entry |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up duration: 8 years |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | CépiDC, letters to the municipalities of birth |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.hal.inserm.fr/SUVIMAX |
| Description | List of publications in HAL |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=SUVIMAX+OR+SU.VI.MAX+OR+Suppl%C3%A9mentation+en+Vitamines+et+Min%C3%A9raux+Antioxydants+NOT+animals |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Possible data utilization for other researches. Evaluation of the pertinence of the project, of its financing and its feasibility. Establishment of a convention for the industrials. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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