TEXTO : Total EXposure To Organic Pollutants

Healthy Clinical Trial

— TEXTO  

Official title:

TEXTO : Total EXposure To Organic Pollutants

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02210299
• Other study ID #: 35RC13_8917_TEXTO
• Secondary ID: 2014-A00782-4514
• Status: Withdrawn
• Phase: N/A
• First received: August 5, 2014
• Last updated: June 9, 2015
• Start date: September 2014
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 18 Months

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Exposure study
Sampling of blood, food, water, air and dust and delivery of dietary questionnaire

Locations

Country	Name	City	State
France	Rennes Hospital University	Rennes	Brittany

Sponsors (5)

Lead Sponsor	Collaborator
Rennes University Hospital	Agence Nationale de Sécurité Sanitaire de l'alimentation de l'Environnement et du Travail, Institut de Recherche en Santé, Environnement et le Travail, France, Institut National de l'Environnement Industriel et des Risques, Laboratoire d'Etude des Résidus et Contaminants dans les Aliments

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility recruitment	Main objective of this feasibility study is to set the scientific consortium to recruit and study 2 young children's exposures.; Main judgement criteria : Effective enrolment of 2 young children during their consultation to Rennes hospital, from those having a blood sampling for medical purposes, and house survey.	3 months	No
Secondary	Protocol validation	Second objective is to validate protocols, procedures and methods to study exposure to PFAS.; Secondary judgment criteria : Possibility to sample an extra volume of blood, to prepare it and transport it at -18°C to Laberca lab, Nantes; Possibility to organize a home visit with sampling of diet, water, air, dust and delivery of dietary questionnaire; Possibility to quantify PFAS in dietary and environmental samples; Possibility to model the internal dose for some compounds from kinetics data, and to compare doses estimated from blood measurements to those from environmental and diet measurements	1 year	No