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Completed

NCT Number: NCT06045234

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

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.

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Key information

Conditions

Toxicology

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Limoges

Limoges, 87042, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urine sampling

Other

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).

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: VESTAL

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 21, 2023
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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