TEXTO : Total EXposure To Organic Pollutants

NCT ID: NCT02210299

Last Updated: 2015-06-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-05-31

Brief Summary

People are, especially in industrialized countries, exposed to a growing number of ubiquitous chemical substances. It thus increases human exposure pathways: diet, inhalation, soil and dust dermal contact…), notably for semi-volatile organic compounds. Diet is generally sought to contribute the most to total exposure for many chemicals, the relative contribution of each pathway is nevertheless poorly described, and can be different among populations. This is in particularly the case For young children, who can be more exposed via the environment, because of frequent contact with object and dust and hand to mouth behaviors. Children are in addition considered more sensitive to chemical risk due to their maturating systems.

In this context, the objective of this project is to characterize the young children's exposure to a particular class of semi volatile organic compounds. It will encompass the relative contribution of different pathways to the external dose, and to try to match the internal and external doses with a physiologically based pharmacokinetic (PBPK) model for molecules for which it is possible.

The present demand concerns a feasibility study on 2 children, for Perfluorinated Alkylated Substances (PFAS), used in numerous consumer products.

Detailed Description

Pilot study for testing feasibility of cross sectional integrative exposure study.

Strategy : Exposure assessment of young children to PFAS with simultaneous measurement of internal (serum) and external doses (diet, indoor environment: contamination data and human exposure factors; quantity ingested and breathed).

Expected outcomes :

Assessment of feasibility to obtain:

• original data on children's body burden
• original contamination data for food, water, air and dust ;
• Matching of these data to identify main sources and pathways of exposure.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Exposure study

2-6 months-old children and 12-18 months-old children

Group Type: OTHER

Exposure study

Intervention Type: OTHER

Sampling of blood, food, water, air and dust and delivery of dietary questionnaire

Interventions

Exposure study

Sampling of blood, food, water, air and dust and delivery of dietary questionnaire

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Young children (2-6 months ; 12-18 months)

• In outpatient pediatric or pediatric surgery ;
• From their homes ;
• With home located less than 30km from Rennes ;
• Living at their home (not at childcare facility or child-minder);
• With a scheduled blood sampling apart from this study ;
• For child 2 - 6 months :
• With diet exclusively based on milk (maternal exclusively or commercial exclusively)
• In case of breastfeeding, with mother accepting milk sampling ;
• With a free, enlightened and signed written consent from the parents.

Breastfeeding mother :

• > 18 years ;
• Exclusive breastfeeding ;
• With a free, enlightened and signed written consent.

Exclusion Criteria

Children :

• Metabolic illness ;
• Renal or hepatic insufficiency ;
• Malabsorption
• With known HIV+, HBV+, HCV+, CMV+ serology
• Simultaneously participating to other biomedical survey

For breastfeeding mother :

• Under legal protection (judicial protection, guardianship) ;
• mixed breastfeeding ;
• with Known HIV+, HBV+, HCV+, CMV+ serology

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut de Recherche en Santé, Environnement et le Travail, France

OTHER

Sponsor Role: collaborator

Laboratoire d'Etude des Résidus et Contaminants dans les Aliments

UNKNOWN

Sponsor Role: collaborator

Institut national de l'environnement industriel et des risques

INDUSTRY

Sponsor Role: collaborator

National Agency for Sanitary Safety of the Food of the Environment and Labor

OTHER_GOV

Sponsor Role: collaborator

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Glorennec, PhD

Role: STUDY_CHAIR

Inserm UMR 1085 - Institut de Recherche sur la Santé, l'Environnement et le Travail

Florence Rouget, MD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

Rennes Hospital University

Rennes, Brittany Region, France

Countries

France

Other Identifiers

2014-A00782-45

Identifier Type: OTHER

Identifier Source: secondary_id

14/25-941

Identifier Type: OTHER

Identifier Source: secondary_id

140682B-82

Identifier Type: OTHER

Identifier Source: secondary_id

35RC13_8917_TEXTO

Identifier Type: -

Identifier Source: org_study_id