Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06653660
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-09-06
Brief Title:
Exposure to Organochlorine Pollutants and Impact on Development in the Peripubertal Age in Guadeloupe
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Exposure to Organochlorine Pollutants and Impact on Development in the Peripubertal Age in Guadeloupe
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TIMOUNPUBERTY
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None