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Temporal Variation of the Exposure to Pesticides in the Employees of the Limoges University Hospital (VESTAL)

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ClinicalTrials.gov Identifier: NCT06045234
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : February 1, 2024
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Study Description
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Brief Summary:
In a sample of 300 employees of the Limoges University Hospital, it is proposed to explore the intraindividual and interindividual variability of urinary concentrations of glyphosate and 320 other pesticides. The employees will fill a questionary in which will allow to explore the relationships between the concentrations, lifestyle and dietary habits.

Condition or disease Intervention/treatment Phase
Toxicology Other: Urine sampling Not Applicable

Detailed Description:

The general population is exposed to pesticides through the ingestion of food and water. The presence of pesticides in human urine has been demonstrated in numerous studies. Conventionally, biological monitoring studies use an undifferentiated urine sample or the first morning urine. The reliability of measuring a single-point urinary concentration to represent the profile of pesticide exposure in individuals over time is, however, questionable. Rare studies reporting intra-individual outcomes of pesticide exposure have been conducted in specific populations, such as children and pregnant women.

It is proposed to carry out a descriptive biomonitoring study of the urinary concentration of approximately 320 pesticides in a sample of the general population. Among these, the study will focus on glyphosate.

The originality of our study is:

  • (i) Exploration of exposure to the main pesticides in a sample of 300 people by measuring urinary concentration by specific and sensitive methods of LC-MS/MS and GC-MS/MS; These 300 subjects will be hospital staff of the Limoges University Hospital.
  • (ii) Exploration of the intra-individual variability of exposure by repeating measurements in urine samples taken over a 24-hour period and/or several times over the course of a week;
  • (iii) Determination of the frequency of subjects who have potentially been exposed to doses higher than the acceptable daily intake (in particular for glyphosate) (iv) The association of these exposure values with data from a self-administered questionnaire in order to identify the determinants of this exposure
  • (V) Estimating the predictability/reliability of a single urine sample to represent this exposure of individuals/populations over time.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Temporal Variation of the Exposure to Pesticides in the Employees of the Limoges University Hospital
Actual Study Start Date : October 17, 2023
Estimated Primary Completion Date : October 17, 2024
Estimated Study Completion Date : October 23, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Pesticide measurement Other: Urine sampling

Among the 300 people recruited:

  • 300 will each provide 3 urine samples collected on 3 different days during a week (e.g. Monday, Wednesday and Friday)
  • 50 will each provide 3 urine samples collected at sunrise, in the middle and then at the end of the day over a period of 24 hours, on 3 different days during a week (e.g. Monday, Wednesday and Friday).


Outcome Measures
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Primary Outcome Measures :
  1. glyphosate overconsumption [ Time Frame: 1 week ]
    Proportion of individuals with an estimated daily consumption of glyphosate greater than the acceptable daily intake of glyphosate


Secondary Outcome Measures :
  1. Identification of determinant of exposure to glyphosate [ Time Frame: 1 week ]
    Proportion of individuals with a daily consumption of glyphosate greater than the acceptable daily intake according to socio-demographic determinants(age, sex, profession and socio-professional category)

  2. Identification of determinant of exposure to glyphosate [ Time Frame: 1 week ]
    Proportion of individuals with a daily consumption of glyphosate greater than the acceptable daily intake according to lifestyles (city center, peri-urban, rural )

  3. Identification of determinant of exposure to glyphosate [ Time Frame: 1 week ]
    Proportion of individuals with a daily consumption of glyphosate greater than the acceptable daily intake according to proximity to agricultural activities

  4. Identification of determinant of exposure to glyphosate [ Time Frame: 1 week ]
    Proportion of individuals with a daily consumption of glyphosate greater than the acceptable daily intake according to use of glyphosate at home

  5. Identification of determinant of exposure to glyphosate [ Time Frame: 1 week ]
    Proportion of individuals with a daily consumption of glyphosate greater than the acceptable daily intake according to dietary habits

  6. Coefficient of variation of the glyphosate concentrations [ Time Frame: 1 week ]
    Calculation of the coefficient of variation of the glyphosate concentrations measured 3 times over a period of 24 hours

  7. Intra-individual variability of urinary glyphosate concentrations [ Time Frame: 1 week ]
    Comparison of the average GLP concentrations measured on 3 occasions (at sunrise, in the middle then at the end of the day) over a period of 24 hours.

  8. Impact of urine sample collection schedule on glyphosate concentration measurement [ Time Frame: 1 week ]
    According to the methodology proposed by Wang et al. : a linear mixed-effects model to determine which measure produces the best estimate of exposure; itself obtained by calculating the mean of the observed values.

  9. Identification of determinants of exposure to a panel of around 320 pesticides [ Time Frame: 1 week ]
    Proportion of subjects with a detectable concentration among the 320 pesticides measured by specific LC-MS and GC-MS methods and prevalence of individuals with a detectable concentration according to socio-demographic determinants

  10. Identification of determinants of exposure to a panel of around 320 pesticides [ Time Frame: 1 week ]
    Proportion of subjects with a detectable concentration among the 320 pesticides measured by specific LC-MS and GC-MS methods and prevalence of individuals with a detectable concentration according to lifestyles

  11. Identification of determinants of exposure to a panel of around 320 pesticides [ Time Frame: 1 week ]
    Proportion of subjects with a detectable concentration among the 320 pesticides measured by specific LC-MS and GC-MS methods and prevalence of individuals with a detectable concentration according to proximity to agricultural activities

  12. Identification of determinants of exposure to a panel of around 320 pesticides [ Time Frame: 1 week ]
    Proportion of subjects with a detectable concentration among the 320 pesticides measured by specific LC-MS and GC-MS methods and prevalence of individuals with a detectable concentration according to use of glyphosate at home

  13. Identification of determinants of exposure to a panel of around 320 pesticides [ Time Frame: 1 week ]
    Proportion of subjects with a detectable concentration among the 320 pesticides measured by specific LC-MS and GC-MS methods and prevalence of individuals with a detectable concentration according to dietary habits

  14. Intra-individual variability of urinary 320 pesticides concentrations [ Time Frame: 1 week ]
    Calculation of the coefficient of variation of the concentrations of each of the pesticides (expressed in µg/L or µg/g of creatinine) measured 3 times (at sunrise, in the middle and then at the end of the day) over a period of 24 hours

  15. Impact of urine sample collection schedule on 320 pesticides concentration measurement [ Time Frame: 1 week ]
    Comparison of the average concentrations of each of the pesticides measured on 3 occasions (at sunrise, in the middle and then at the end of the day) over a period of 24 hours. According to the methodology proposed by Wang et al.: a linear mixed-effects model to determine which measure produces the best estimate of exposure; itself obtained by calculating the mean of the observed values.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult 18 years and over.
  • Employed by the University Hospital of Limoges.
  • Having consented to participate in the study after being informed.

Exclusion Criteria:

- Adult with a professional activity during which he is required to handle or come into contact with glyphosate

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06045234


Contacts
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Contact: Franck SAINT-MARCOUX, Pharm D 555056143 ext +33 franck.saint-marcoux@chu-limoges.fr

Locations
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France
CHU de Limoges Recruiting
Limoges, France, 87042
Contact: Rachel FROGET, MD       rachel.froget@chu-limoges.fr   
Contact: Fabienne MARIAUD, MD       fabienne.mariaud@chu-limoges.fr   
Principal Investigator: MARIAUD Fabienne, MD         
Sponsors and Collaborators
University Hospital, Limoges
More Information
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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT06045234    
Other Study ID Numbers: 87RI23_0014 (VESTAL)
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: February 1, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Limoges:
Pesticides
general population
measurement