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Supplémentation en Vitamines et Minéraux Antioxydants Study (The) [SU.VI.MAX] Download as PDF

GENERAL INFORMATION

Name Supplémentation en Vitamines et Minéraux Antioxydants Study (The)
Acronym SU.VI.MAX
Last update 11/12/2012

Affiliation

Principal investigator

Serge Hercberg (M.D., PhD)
U557 Inserm/ U1125 Inra/CNAM/P13

Contact

Serge Hercberg (M.D., PhD)
INSERM
Bobigny F-93017
Phone: 33148388932
Email: hercberg@uren.smbh.univ-paris13.frMail

Website

No information available

Funding agency

Percentage Category
Institut national de la recherche agronomique (INRA) -- public
Institut National de la Santé Et de la Recherche Médicale INSERM -- public
Unilever -- Industry
L'Oréal -- Industry
Kellogg's -- Industry

OBJECTIVES

The objective of the "SUpplementation en VItamines et Minéraux AntioXydants" (SU.VI.MAX) study, was to test in a randomised, placebo-controlled trial, if an adequate and well balanced intake of antioxidant nutrients reduces the incidence of cancers and ischaemic vascular diseases in a middle-age general population.

Research Focus

  • No Broad approach with no specific target of interest (study built as an infrastructure for a broad range of unspecified scientific activities/questions).
  • Yes Target specific questions of interest (predefined scientific targets like, cardiovascular diseases, social environment, specific health trajectories etc.)
Topics ICD-10 classificationExternal
Yes Neoplasms (C00-D48)
Yes Endocrine, nutritional and metabolic diseases (E00-E90)
Yes Diseases of the circulatory system (I00-I99)
Yes Diseases of the skin and subcutaneous tissue (L00-L99)

METHODS

Legend Yes No Unknown

General design

Study design Clinical trial / intervention trial
Type of participants Individuals
Target or final number of participants 12741
Target or final number of DNA 12741

Participant selection / Characteristics of the population

Selection criteria

Yes Age Minimun: 35 years    Maximun: 65 years
Yes Country of residence France

Data Sources

  Cross-sectional Longitudinal follow-up
Yes Questionnaires to participants/respondents No Yes
Yes Direct physical measures No Yes
Yes Biological samples No Yes

Sample management

Biological samples

Yes Blood No Buccal cells
No Cord blood No Tissues
No Saliva No Urine

Genome-Wide Association (GWA) analyses

  • Yes Already or currently generating GWA data.

GOVERNANCE

Legend Yes No

Allow access to data or samples to external researchers

Academia Industry
Yes Data (questionnaire-derived, measured…) Yes
Yes Biological samples Yes

STATUS

Current status

Phase Start End
Preparation phase/Pilot 1991 1994
Baseline recruitment / initial data collection 1994 1995
Follow-up of participants 1994 2009
Study ended   2008

Supplementary informations

post supplementation period: 2003-2008

Current number of participants recruited 12741 in date of 06/01/1995
Current number of collected DNA samples 12741 in date of 06/01/1995

DOCUMENTATION


General Information

Study name Supplémentation en Vitamines et Minéraux Antioxydants Study (The) [SU.VI.MAX]
Last update 05/08/2008

Contact

Pilar Galan (MD, PhD)
 Inserm U557/Inra/Cnam/P13
Bobigny F-93017
Phone: 33 1 48 38 89 32
Email: p.galan@uren.smbh.univ-paris13.frMail

Quality Management Steps

Yes Sampling
Yes Shipment
Yes Processing
Yes Storage
Yes Distribution
Yes Data Management and IT

Biosecurity measures implementation

Yes Biosecurity measures implemented

Comments

The extraction, stockage and management of the samples is done in collaboration with the CNG (Centre National de Génotypage - Pr M. Latrop and Pr K. Clement, INSERM Nutriomique U872 (Eq 7)).

Samples

Legend Yes No
Sample name Blood
  Main laboratory
  Sample labels/traceability (% of samples)
  • No RFID radio frequency identification
  • Yes Barcode (1D)
  • Yes Printed labels
  • No Handwritten numbers
  • Yes Others (+C3)
Pre-extraction sample storage format Substrate storage condition
  • No Fresh
  • No Refrigerated
  • Yes Frozen (-80°C)
  • No Dried (paper)
  • No Liquid Nitrogen
  • No Other
Substrate storage period
  • No Short term
  • Yes Long term
DNA extraction DNA extraction method
  • Yes Salting out
  • Yes Phenol-chloroform
  • No Columnary-extraction
  • No Magnetic beads
  • No Oragene (saliva)
  • No Others
Automation of handling
  • No Manual
  • Yes Automated
DNA handling and storage DNA diluent
  • Yes TE
  • No H2O
  • No Others
DNA concentration (ng/µl)
Storage conditions
  • Yes 4°C (short term)
  • Yes -20°C (long term)
  • No -40°C
  • No -80°C
  • No Dried
  • No Others
Protocols DNA concentration between 100-150 ng/uL on average.
DNA quantification Methods
  • No A260/A280
  • Yes Picogreen
  • No Nanodrop
  • No Others
Technical quality
  • No Automated
  • Yes Manual
  • No Reproducibility
DNA quality control Percentage of samples that are tested 10.0
DNA quality method
  • Yes Agarose gel
  • Yes PCR
  • No A260/A280 ratio
  • No Others
DNA analysis Platforms
  • No Gentoyping
  • No Sequencing
  • No Methylation
  • No CNVs
  • No CGH
  • No FISH
  • No Other
Technical quality
  • No Automated
  • No Manual
  • No Reproducibility

General Information

Study name Supplémentation en Vitamines et Minéraux Antioxydants Study (The) [SU.VI.MAX]
Last update 02/05/2010

Contact

Pilar Galan (MD, PhD)
Inserm U557/Inra/Cnam/P13
Bobigny F-93017
Phone: 33 1 48 38 89 32
Email: p.galan@uren.smbh.univ-paris13.frMail

Software

Legend Yes No

Software overview

Biobanking areas covered SAS 9.1.3External Intranet suvimax
Participant recruitment (ex: CATI, CRM) Yes
Data collection Yes
Sample collection, storage and processing Yes
Data repository Yes
Other
 
Programming language SAS 9.1.3External Intranet suvimax
Name and version of programming language sas PhP 4 , SGBD PostgreSQL 7.3
 
Internal/external development SAS 9.1.3External Intranet suvimax
In-house by IT department Yes
By an external company Yes
 
Shareability SAS 9.1.3External Intranet suvimax
Freely available
Purchaseable Yes
Needs extensive work
Not for share Yes

Software details

Biobanking areas covered

  • No Participant recruitment (ex: CATI, CRM)
  • No Data collection
  • No Questionnaires (ex: CAPI)
  • No Physical and cognitive measures
  • No Sample collection, storage and processing
  • No Collection
  • No Sample bio-repository management system (ex: sample storage management software)
  • No LIMS (ex: biochemical analysis, DNA extraction, genotyping)
  • Yes Data repository
  • Yes Data warehousing
  • No Study monitoring (ex: quality control)
  • Yes User data / sample request management

Name and version of programming language

sas

Internal/external development

  • No In-house by IT department
  • Yes By an external company (SAS Institute Inc)

Shareability

  • No Freely available
  • Yes Purchaseable
  • No Needs extensive work
  • No Not for share

Url

Biobanking areas covered

  • Yes Participant recruitment (ex: CATI, CRM)
  • Yes Data collection
  • Yes Questionnaires (ex: CAPI)
  • No Physical and cognitive measures
  • Yes Sample collection, storage and processing
  • Yes Collection
  • No Sample bio-repository management system (ex: sample storage management software)
  • No LIMS (ex: biochemical analysis, DNA extraction, genotyping)
  • No Data repository
  • No Data warehousing
  • No Study monitoring (ex: quality control)
  • No User data / sample request management

Name and version of programming language

PhP 4 , SGBD PostgreSQL 7.3

Internal/external development

  • Yes In-house by IT department
  • No By an external company

Shareability

  • No Freely available
  • No Purchaseable
  • No Needs extensive work
  • Yes Not for share

Comments

No information available

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