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

NCT ID: NCT06653660

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

650 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-19

Study Completion Date

2026-12-19

Brief Summary

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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

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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

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Prenatal Exposure Postnatal Exposure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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peripubertal children

Children born from a mother whose pregnancy was included in the Timoun cohort (2004 -2007).

Clinical examination

Intervention Type OTHER

For 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.

Interventions

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Clinical examination

For 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.

Intervention Type OTHER

Other Intervention Names

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Blood collection, cognitive tests

Eligibility Criteria

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Inclusion Criteria

* Be born to a mother whose pregnancy was included in the Timoun cohort (2004 - 2007) and whose parents agreed to be contacted later.
* Residing in Guadeloupe at the peripubertal age
* Affiliation to a social security scheme
* Agreement to participate in the study and informed consent signed by the minor
* Study participation agreement and informed consent signed by the parents

Exclusion Criteria

* Refusal to participate in the research
Minimum Eligible Age

16 Years

Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

Centre Hospitalier Universitaire de la Guadeloupe

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gulen AYHAN

Role: PRINCIPAL_INVESTIGATOR

CHU of Guadeloupe

Locations

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CHU of Guadeloupe

Pointe-à-Pitre, Guadeloupe, Guadeloupe

Site Status RECRUITING

Countries

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Guadeloupe

Central Contacts

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Valérie HAMONY-SOTER

Role: CONTACT

+590 590 93 46 77

Eunice NUBRET

Role: CONTACT

+590 590 93 46 86

Facility Contacts

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Gulen AYHAN

Role: primary

+590 590 89 43 80

Luc MULTIGNER

Role: backup

+33 (0) 6 09 41 91 01

Other Identifiers

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PAP_RI2_2019/11

Identifier Type: -

Identifier Source: org_study_id

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