TEXTO : Total EXposure To Organic Pollutants — TEXTO  

Healthy Clinical Trial

Official title: TEXTO : Total EXposure To Organic Pollutants

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

• NCT number: NCT02210299
• Study type: Interventional
• Source: Rennes University Hospital
• Status: Withdrawn
• Phase: N/A
• Start date: September 2014
• Completion date: May 2015