Clinical trial NCT06653660: Exposure to Organochlorine Pollutants and Impact on Development in the Peripubertal Age in Guadeloupe
Official title: Exposure to Organochlorine Pollutants and Impact on Development in the Peripubertal Age in Guadeloupe
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prenatal Exposure
Postnatal Exposure
Keywords: Prenatal Exposure
Postnatal Exposure
Chlordecone
Persistent Organic Pollutants
Endocrine disruptors
Puberty
Development
Guadeloupe
French West Indies
Lead sponsor: Centre Hospitalier Universitaire de la Guadeloupe
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2024-10-22
Enrollment: 650
Sex: ALL
Minimum age (years): 16
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Be born to a mother whose pregnancy was included in the Timoun cohort (2004 - 2007)

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: Scores from cognitive development tests estimating verbal comprehension verbal comprehension, perceptual reasoning and working memory
timeFrame: At the start of the study (inclusion visit)
Secondary outcomes:
measure: Age at onset of pubertal development (onset of accelerated growth acceleration of growth rate, modeled on growth curves)
timeFrame: At the start of the study (inclusion visit).
Other outcomes:
measure: Age at established puberty (period for girls, molting for boys)
timeFrame: At the start of the study (inclusion visit) or through study completion, an average of two years, for girls who had their period and boys molted.
measure: Plasma concentrations of steroid hormones
timeFrame: At the start of the study (inclusion visit).
measure: Blood pressure
timeFrame: At the start of the study (inclusion visit).
measure: heart rate
timeFrame: At the start of the study (inclusion visit).
Locations:
city: Pointe-à-Pitre
country: Guadeloupe
facility: CHU of Guadeloupe
Study officials:
affiliation: CHU of Guadeloupe
name: Gulen AYHAN
role: PRINCIPAL_INVESTIGATOR
References: