Nutrivigilance - Longitudinal study on general population : monitoring the safety of food supplements
Head :
Vo Van-Regnault Gwenn
Last update : 10/23/2017 | Version : 1 | ID : 73040
| General | |
| Identification | |
| Detailed name | Longitudinal study on general population : monitoring the safety of food supplements |
| Sign or acronym | Nutrivigilance |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL 1805396 |
| General Aspects | |
| Medical area |
General practice |
| Health determinants |
Intoxication Nutrition |
| Scientific investigator(s) (Contact) | |
| Name of the director | Vo Van-Regnault |
| Surname | Gwenn |
| Phone | +33 (0)1 49 77 11 76 |
| gwenn.vovanregnault@anses.fr | |
| Organization | Anses |
| Collaborations | |
| Participation in projects, networks and consortia |
No |
| Funding | |
| Funding status |
Public |
| Details | Anses (French agency for food, environnemental and occupational health & safety ) |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Anses (French agency for food, environnemental and occupational health & safety ) |
| Organisation status |
Public |
| Presence of scientific or steering committees |
No |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| Database recruitment is carried out by an intermediary |
A selection of health care professionals A selection of health institutions and services |
| Database recruitment is is made on the basis of: |
Another treatment or procedure |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective |
The aim is to monitor the safety of food supplements / food fortified with nutritional or physiological substances / novel foods / foods for particular diet under their actual conditions of use by identifying and analyzing the adverse effects that may be related to their consumption
|
| Inclusion criteria | All cases of adverse effects reported by a health professional (doctor, pharmacist, etc.) |
| Population type | |
| Age |
Newborns (birth to 28 days) Infant (28 days to 2 years) Early childhood (2 to 5 years) Childhood (6 to 13 years) Adolescence (13 to 18 years) Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
General population |
| Pathology | |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2009 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | Declarations <4000 ; Declarants <1000 ; Products <2000 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data Administrative data |
| Clinical data (detail) |
Direct physical measures |
| Declarative data (detail) |
Internet self-questionnaire |
| Presence of a biobank |
No |
| Health parameters studied |
Others |
| Procedures | |
| Participant monitoring |
No |
| Followed pathology | |
| Links to administrative sources |
Yes |
| Promotion and access | |
| Promotion | |
| Access | |
| Dedicated website | https://pro.anses.fr/nutrivigilance/ |
| Terms of data access (charter for data provision, format of data, availability delay) | Upon a reasoned request to ANSES. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
