Trials / Withdrawn
WithdrawnNCT02210299
TEXTO : Total EXposure To Organic Pollutants
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Rennes University Hospital · Academic / Other
- Sex
- All
- Age
- 6 Months – 18 Months
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Exposure study | Sampling of blood, food, water, air and dust and delivery of dietary questionnaire |
Timeline
- Start date
- 2014-09-01
- Primary completion
- 2015-05-01
- Completion
- 2015-05-01
- First posted
- 2014-08-06
- Last updated
- 2015-06-10
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT02210299. Inclusion in this directory is not an endorsement.