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Trials / Recruiting

RecruitingNCT06653660

Exposure to Organochlorine Pollutants and Impact on Development in the Peripubertal Age in Guadeloupe

Status
Recruiting
Phase
Study type
Observational
Enrollment
650 (estimated)
Sponsor
Centre Hospitalier Universitaire de la Guadeloupe · Academic / Other
Sex
All
Age
16 Years – 22 Years
Healthy volunteers
Not accepted

Summary

In the context of environmental pollution of the French West Indies by chlordecone and questions about health consequences, monitoring at the peripubertal age of children born alive in the TIMOUN cohort is justified in several respects: - existence of an already established mother-child cohort whose live-born children will reach peripubertal ages during the period 2020-2022; - opportunity to verify hypotheses put forward on the basis of toxicological data acquired in laboratory animals and the hormonal characteristics of chlordecone (endocrine disruptor); - strong societal demand for such research to be carried out because of concerns about the sensitivity of children and adolescents to the effects of environmental xenobiotics, in particular on sexual development and the age of puberty; - recommendation of the Scientific Council Chlordecone Inserm - InVS; specific action of the National Plan Chlordecone IV.

Detailed description

The French West Indies are permanently polluted by chlordecone. It is an organochlorine insecticide used from 1973 to 1993 in Guadeloupe and Martinique to control banana root borers. Its physico-chemical properties give it great stability and are at the origin of its persistence in the environment. Soil, flora and wildlife pollution from chlordecone in the Caribbean was first documented shortly after its introduction in 1973. However, it was not until 1999 that this pollution was extended to waters intended for human consumption and to various local, vegetable and animal, land and aquatic foodstuffs. The population is also affected, as confirmed by impregnation studies, with exposure nowadays occurring mainly through the consumption of contaminated food. The contamination of the French West Indies populations by this insecticide raises many questions about its possible health consequences. In order to assess the effects of chlordecone exposure on child development in Guadeloupian children, a longitudinal and prospective study, the Timoun mother-child cohort, was initiated. Between 2004 and 2007, women in the second trimester of pregnancy who planned to give birth in the public hospitals of Grande-Terre and Basse-Terre (accounting for 70% of all deliveries in Guadeloupe) were invited to participate in the study. Children born to these included women have been enrolled to several follow-ups during the last years (3, 7, 18 months and 7 years of age).

Conditions

Interventions

TypeNameDescription
OTHERClinical examinationFor the aim of the present study, we will follow-up children born alive in the TIMOUN cohort at peripubertal age. Questionnaires will be administered to parents on the child's health and lifestyle. Stature-weight anthropometric and cardio-dynamic measurements of the child will be obtained. Scores on three cognitive tests will be obtained. Furthermore, steroid hormones and chlordecone in the child's peripheral blood will be determined.

Timeline

Start date
2022-12-19
Primary completion
2026-12-19
Completion
2026-12-19
First posted
2024-10-22
Last updated
2025-11-17

Locations

1 site across 1 country: Guadeloupe

Source: ClinicalTrials.gov record NCT06653660. Inclusion in this directory is not an endorsement.