ToxicologyVESTALNCT06045234
Temporal Variation of the Exposure to Pesticides in the Employees of the Limoges University Hospital
A study testing Urine sampling in people with Toxicology, run by University Hospital, Limoges at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Toxicology
- What is being tested?
- Urine sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 17 Oct 2023to 2 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult 18 years and over.
- Employed by the University Hospital of Limoges.
- Having consented to participate in the study after being informed.
Who cannot join
- Adult with a professional activity during which he is required to handle or come into contact with glyphosate
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Toxicology
- Being tested
- Urine sampling
- Keywords
- Pesticides, general population, measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine samplingOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Pesticide measurement | Experimental | Not described Receives: Other: Urine sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
glyphosate overconsumption
Proportion of individuals with an estimated daily consumption of glyphosate greater than the acceptable daily intake of glyphosate
Measured: 1 week
Secondary outcomes (15)
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)
Measured: 1 week
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 )
Measured: 1 week
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
Measured: 1 week
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
Measured: 1 week
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
Measured: 1 week
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
Measured: 1 week
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.
Measured: 1 week
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.
Measured: 1 week
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
Measured: 1 week
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
Measured: 1 week
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
Measured: 1 week
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
Measured: 1 week
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
Measured: 1 week
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
Measured: 1 week
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start17 Oct 2023
- Primary completion2 Aug 2024
- Study completion2 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ToxicologyStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045234
- Sponsor's protocol ID
- 87RI23_0014 (VESTAL)
- Acronym
- VESTAL
- Status last verified
- Jan 2025
- First submitted
- 13 Sep 2023
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Variation of the Exposure to Pesticides in the Employees of the Limoges University Hospital
- ClinicalTrials.gov ID
- NCT06045234
- Acronym / sponsor ID
- VESTAL / 87RI23_0014 (VESTAL)
- Conditions
- Toxicology
- Keywords
- Pesticides, general population, measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 2 Aug 2024 (actual)
- Study completion
- 2 Aug 2024 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pesticide measurement | Experimental | Other: Urine sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult 18 years and over.
- Employed by the University Hospital of Limoges.
- Having consented to participate in the study after being informed.
Key exclusion criteria (1 listed)
- Adult with a professional activity during which he is required to handle or come into contact with glyphosate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine samplingAmong 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). | Other | Pesticide measurement |
Primary outcome
glyphosate overconsumption
Time frame: 1 week
Proportion of individuals with an estimated daily consumption of glyphosate greater than the acceptable daily intake of glyphosate
15 secondary outcomes
Identification of determinant of exposure to glyphosate
Time frame: 1 week
Identification of determinant of exposure to glyphosate
Time frame: 1 week
Identification of determinant of exposure to glyphosate
Time frame: 1 week
Identification of determinant of exposure to glyphosate
Time frame: 1 week
Identification of determinant of exposure to glyphosate
Time frame: 1 week
Coefficient of variation of the glyphosate concentrations
Time frame: 1 week
Intra-individual variability of urinary glyphosate concentrations
Time frame: 1 week
Impact of urine sample collection schedule on glyphosate concentration measurement
Time frame: 1 week
Identification of determinants of exposure to a panel of around 320 pesticides
Time frame: 1 week
Identification of determinants of exposure to a panel of around 320 pesticides
Time frame: 1 week
Identification of determinants of exposure to a panel of around 320 pesticides
Time frame: 1 week
Identification of determinants of exposure to a panel of around 320 pesticides
Time frame: 1 week
Identification of determinants of exposure to a panel of around 320 pesticides
Time frame: 1 week
Intra-individual variability of urinary 320 pesticides concentrations
Time frame: 1 week
Impact of urine sample collection schedule on 320 pesticides concentration measurement
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urine sampling in people with Toxicology, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glyphosate overconsumption (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.