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NCT04155463

Measurement of Agricultural and Dietary Glyphosate Exposure Among Pregnant Women

Completed NA Results posted Last updated 14 April 2023
What this trial tests

NA trial testing Organic Diet in Exposure to Herbicides in 40 participants. Completed in 28 December 2021.

Timeline
23 February 2021
Primary endpoint
30 June 2021
28 December 2021

Quick facts

Lead sponsorBoise State University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposebasic science
Enrollment40
Start date23 February 2021
Primary completion30 June 2021
Estimated completion28 December 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Boise State University

Who can join

Adults 18 to 35, female only, with Exposure to Herbicides. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Specific Gravity-adjusted Urinary Glyphosate Concentrations During Conventional and Organic Diet Primary · One week conventional diet and one week organic diet

We collected 531 daily first morning void urine samples. We aliquoted 0.6 mL of each participant's seven daily urine samples to form a composite sample intended to represent each participant's mean glyphosate exposure during each week of the dietary intervention For all 39 participants there was one weekly composite urine sample from the conventional diet period and one weekly composite urine sample from the organic diet period. These 78 composite urine samples were analyzed for glyphosate concentrations and adjusted for urine specific gravity.

All Participants
GroupValue95% CI
Conventional Diet0.190.11 – 0.30
Organic Diet0.170.10 – 0.26
Far-field Participants
GroupValue95% CI
Conventional Diet0.180.11 – 0.31
Organic Diet0.140.10 – 0.23
Near-field Participants
GroupValue95% CI
Conventional Diet0.210.12 – 0.29
Organic Diet0.200.12 – 0.27

Sponsor's own description

The purpose of this research is to understand whether and how pregnant women may be exposed to glyphosate, the active ingredient in a common herbicide. The researchers aim to assess glyphosate exposure among pregnant women in Idaho, and to attribute that exposure to agricultural and dietary sources. Pregnant women who live either near or far from glyphosate-treated fields will be recruited for study inclusion, and exposure will be assessed via urinary biomonitoring on a weekly basis throughout pregnancy. Each participant will also take part in a two-week dietary intervention, during which they will receive one week of organic food and one week of conventional food, in a crossover design. Urinary biomonitoring will occur on a daily basis during the dietary intervention phase. The researchers hypothesize that women who live near agricultural fields treated with glyphosate will have higher exposures than those who live in non-agricultural regions, and that consumption of an organic diet will reduce exposures in both groups. All study components will be completed with no face-to-face interaction to eliminate all coronavirus (COVID-19) related risks.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing