Measurement of Agricultural and Dietary Glyphosate Exposure Among Pregnant Women
Other study identifiers
Sponsor study identifier
NIH
Secondary identifiers
NIH
interventional
40
1 country
1
Study Start
February 23, 2021
Actual (reported)Primary Completion
June 30, 2021
Actual (reported)Study Completion
December 28, 2021
Actual (reported)Brief Summary
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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- completed
- Actual enrollment (reported)
- 40 participants
- Study completion date
December 28, 2021
Actual (reported)- Listed locations
- 1 countries · 1 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
November 5, 2019
Actual (reported)First Posted
November 7, 2019
Actual (reported)Study Start
February 23, 2021
Actual (reported)Primary Completion
June 30, 2021
Actual (reported)Study Completion
December 28, 2021
Actual (reported)Results Posted
April 14, 2023
Actual (reported)
- Last Updated
- April 14, 2023
- Status Verified
- April 2023
- Results QC Date
- April 13, 2023
- Last Update Submitted
- April 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Specific Gravity-adjusted Urinary Glyphosate Concentrations During Conventional and 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.
One week conventional diet and one week organic diet
Study Arms (2)
Organic Diet, Then Conventional Diet:
EXPERIMENTALThese participants first received an organic diet for one week. During that week, daily first morning void urine samples were collected. After a washout period of one day, these participants then received a conventional (non-organic) diet for one week. During that week, daily first morning void urine samples were collected. For each week, participants ordered all food they anticipated eating that week (up to $150) from a unique account with a local grocery store in accordance with either the organic diet or conventional diet. Study staff verified all food items corresponded with the dietary intervention that week, and then ordered the groceries to be delivered to the participant's home, when possible. For participants living in areas in which delivery was not available (generally rural areas), study staff picked up the food at the grocery store and delivered it to the participant's home.
Conventional Diet, Then Organic Diet
EXPERIMENTALThese participants first received a conventional (non-organic) diet for one week. During that week, daily first morning void urine samples were collected. After a washout period of one day, these participants then received an organic diet for one week. During that week, daily first morning void urine samples were collected. For each week, participants ordered all food they anticipated eating that week (up to $150) from a unique account with a local grocery store in accordance with either the organic diet or conventional diet. Study staff verified all food items corresponded with the dietary intervention that week, and then ordered the groceries to be delivered to the participant's home, when possible. For participants living in areas in which delivery was not available (generally rural areas), study staff picked up the food at the grocery store and delivered it to the participant's home.
Interventions
Participants receive one week of organic food. Organic food is certified through the USDA's National Organic Program as produced without the use of synthetic pesticides, including glyphosate.
Participants receive one week of conventionally grown (non-organic) food.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Eligibility Criteria
You may qualify if:
- Be in the first trimester of pregnancy
- No diagnosis of gestational diabetes or other high risk pregnancy factors
- Consume an exclusively conventional diet with no intentions to switch to an organic diet
- Agree to refrain from applying residential glyphosate (Round Up) during the study
- Either live more than 10 miles or less than 1 mile from a glyphosate treated field
You may not qualify if:
- \- Occupational exposure to glyphosate, or live in a household with an individual with occupational glyphosate exposure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boise State UniversityOtherlead
- National Institute of Environmental Health Sciences (NIEHS)NIHcollaborator
Study Sites (1)
Boise State University
Boise, Idaho, 83725, United States
Results Point of Contact
- Title
- Dr. Cynthia Curl
- Organization
- Boise State University
Study Officials
- PRINCIPAL INVESTIGATOR
Cynthia Curl, PhD
Boise State University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Enrollment
40 participants (actual enrollment reported by the registry).
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 5, 2019
First Posted
November 7, 2019
Study Start
February 23, 2021
Actual (reported)Primary Completion
June 30, 2021
Actual (reported)Study Completion
December 28, 2021
Actual (reported)Last Updated
April 14, 2023
Results First Posted
April 14, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share
Source record
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
- Registry identifier
- NCT04155463
- Data provider
- ClinicalTrials.gov
- Source updated
- 2023-04-14
- Normalization version
- ctgov-legacy-1
Source retrieved:
Documents
- Protocol2022-06-30
- SAP2022-07-01
- ICF2021-08-17