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

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Métadonnées
Identification
General Aspects
Collaborations
Funding
Governance of the database
Scientific investigator(s) (Contact)
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 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
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
Scientific investigator(s) (Contact)
Name of the director Vo Van-Regnault
Surname Gwenn
Phone +33 (0)1 49 77 11 76
Email gwenn.vovanregnault@anses.fr
Organization Anses
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
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
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

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