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

Toxicology Clinical Trial

— VESTAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06045234
• Other study ID #: 87RI23_0014 (VESTAL)
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2023
• Est. completion date: October 23, 2024

Study information

• Verified date: January 2024
• Source: University Hospital, Limoges
• Contact: Franck SAINT-MARCOUX, Pharm D
• Phone: 555056143
• Email: franck.saint-marcoux[@]chu-limoges.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 23, 2024
• Est. primary completion date: October 17, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Toxicology

Intervention

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).

Locations

Country	Name	City	State
France	CHU de Limoges	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glyphosate overconsumption	Proportion of individuals with an estimated daily consumption of glyphosate greater than the acceptable daily intake of glyphosate	1 week
Secondary	Identification of determinant of exposure to glyphosate	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)	1 week
Secondary	Identification of determinant of exposure to glyphosate	Proportion of individuals with a daily consumption of glyphosate greater than the acceptable daily intake according to lifestyles (city center, peri-urban, rural )	1 week
Secondary	Identification of determinant of exposure to glyphosate	Proportion of individuals with a daily consumption of glyphosate greater than the acceptable daily intake according to proximity to agricultural activities	1 week
Secondary	Identification of determinant of exposure to glyphosate	Proportion of individuals with a daily consumption of glyphosate greater than the acceptable daily intake according to use of glyphosate at home	1 week
Secondary	Identification of determinant of exposure to glyphosate	Proportion of individuals with a daily consumption of glyphosate greater than the acceptable daily intake according to dietary habits	1 week
Secondary	Coefficient of variation of the glyphosate concentrations	Calculation of the coefficient of variation of the glyphosate concentrations measured 3 times over a period of 24 hours	1 week
Secondary	Intra-individual variability of urinary glyphosate concentrations	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.	1 week
Secondary	Impact of urine sample collection schedule on glyphosate concentration measurement	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.	1 week
Secondary	Identification of determinants of exposure to a panel of around 320 pesticides	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	1 week
Secondary	Identification of determinants of exposure to a panel of around 320 pesticides	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	1 week
Secondary	Identification of determinants of exposure to a panel of around 320 pesticides	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	1 week
Secondary	Identification of determinants of exposure to a panel of around 320 pesticides	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	1 week
Secondary	Identification of determinants of exposure to a panel of around 320 pesticides	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	1 week
Secondary	Intra-individual variability of urinary 320 pesticides concentrations	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	1 week
Secondary	Impact of urine sample collection schedule on 320 pesticides concentration measurement	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.	1 week