TEXTO : Total EXposure To Organic Pollutants

NCT02210299 | Withdrawn

• 4 other identifiers: 35RC13_8917_TEXTO2014-A00782-4514/25-941140682B-82
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Healthy young children (2-6 months ; 12-18 months)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Protocol validation

  1 year

Study Arms (1)

Exposure study

OTHER

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

Other: Exposure study

Interventions

Exposure study OTHER

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

Exposure study

Eligibility Criteria

• Age: 6 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead
• Institut de Recherche en Santé, Environnement et le Travail, France: collaborator
• Laboratoire d'Etude des Résidus et Contaminants dans les Aliments: collaborator
• Institut national de l'environnement industriel et des risques: collaborator
• National Agency for Sanitary Safety of the Food of the Environment and Labor: collaborator

Study Sites (1)

Rennes Hospital University

Rennes, Brittany Region, 35033, France

Location

Study Officials

• Philippe Glorennec, PhD

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

  STUDY CHAIR

• Florence Rouget, MD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2014
• First Posted: August 6, 2014
• Study Start: September 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 10, 2015

Record last verified: 2015-06

Locations

FR (1)