Trial Outcomes & Findings for Measurement of Agricultural and Dietary Glyphosate Exposure Among Pregnant Women (NCT NCT04155463)
NCT ID: NCT04155463
Last Updated: 2023-04-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
One week conventional diet and one week organic diet
Results posted on
2023-04-14
Participant Flow
We recruited 40 pregnant women in their first trimester from Women, Infants, and Children (WIC) clinics in Idaho as part of a longitudinal study to examine urinary glyphosate concentrations during pregnancy. We enrolled participants between February 23 and June 3, 2021 and followed them until they gave birth between August 5 and December 28, 2021. Of the 58 individuals referred by WIC clinics, 53 (91%) were eligible; 40 (75%) of eligible individuals were enrolled in the study.
As part of the longitudinal study, we conducted a two-week randomized crossover dietary intervention from June 16-June 30, 2021. 39 of the 40 participants took part in the dietary intervention (one participant was assigned to an arm but was out of town during the intervention). We randomly assigned participants to receive one week of either organic or conventional groceries, followed by one washout day, then one week of groceries of the opposite food type.
Participant milestones
| Measure |
Organic Diet, Then Conventional Diet:
These 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
These 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.
|
|---|---|---|
|
First Intervention (1 Week)
STARTED
|
20
|
20
|
|
First Intervention (1 Week)
COMPLETED
|
20
|
19
|
|
First Intervention (1 Week)
NOT COMPLETED
|
0
|
1
|
|
Washout (1 Day)
STARTED
|
20
|
19
|
|
Washout (1 Day)
COMPLETED
|
20
|
19
|
|
Washout (1 Day)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (1 Week)
STARTED
|
20
|
19
|
|
Second Intervention (1 Week)
COMPLETED
|
20
|
19
|
|
Second Intervention (1 Week)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Organic Diet, Then Conventional Diet:
These 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
These 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.
|
|---|---|---|
|
First Intervention (1 Week)
out of town during dietary intervention
|
0
|
1
|
Baseline Characteristics
This measure applies only to participants who indicated that they "Personally used herbicides at residence in last year" or "Someone else used herbicides at residence in last year" (i.e., this measure only applies to the 6 participants in the "Organic Diet, Then Conventional Diet" Arm and the 2 participants in the "Conventional Diet, Then Organic Diet" Arm that answered "Yes" to "Personally used herbicides at residence in last year" or "Someone else used herbicides at residence in last year.")
Baseline characteristics by cohort
| Measure |
Organic Diet, Then Conventional Diet:
n=20 Participants
These participants first received an organic diet for one week, defined as food certified through the United States Department of Agriculture's National Organic Program as produced without the use of synthetic pesticides, including glyphosate. 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
n=19 Participants
These 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, defined as food certified through the United States Department of Agriculture National Organic Program as produced without the use of synthetic pesticides, including glyphosate.. 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.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-22 years
|
6 Participants
n=20 Participants
|
5 Participants
n=19 Participants
|
11 Participants
n=39 Participants
|
|
Age, Customized
23-27 years
|
4 Participants
n=20 Participants
|
6 Participants
n=19 Participants
|
10 Participants
n=39 Participants
|
|
Age, Customized
28-32 years
|
6 Participants
n=20 Participants
|
7 Participants
n=19 Participants
|
13 Participants
n=39 Participants
|
|
Age, Customized
33-37 years
|
4 Participants
n=20 Participants
|
1 Participants
n=19 Participants
|
5 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=20 Participants
|
19 Participants
n=19 Participants
|
39 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Caucasian or White
|
9 Participants
n=20 Participants
|
11 Participants
n=19 Participants
|
20 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latina
|
10 Participants
n=20 Participants
|
9 Participants
n=19 Participants
|
19 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=20 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
1 Participants
n=20 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
African American or Black
|
0 Participants
n=20 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=39 Participants
|
|
Highest Level of Education
Less than high school
|
2 Participants
n=20 Participants
|
3 Participants
n=19 Participants
|
5 Participants
n=39 Participants
|
|
Highest Level of Education
Graduated high school/earned General Educational Development
|
9 Participants
n=20 Participants
|
5 Participants
n=19 Participants
|
14 Participants
n=39 Participants
|
|
Highest Level of Education
Some college
|
8 Participants
n=20 Participants
|
10 Participants
n=19 Participants
|
18 Participants
n=39 Participants
|
|
Highest Level of Education
Bachelor's degree
|
1 Participants
n=20 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=39 Participants
|
|
Highest Level of Education
Graduate school/advanced degree
|
0 Participants
n=20 Participants
|
1 Participants
n=19 Participants
|
1 Participants
n=39 Participants
|
|
Household income in previous year
< $10,000 - 19,999
|
5 Participants
n=20 Participants
|
4 Participants
n=19 Participants
|
9 Participants
n=39 Participants
|
|
Household income in previous year
$20,000 - 29,999
|
3 Participants
n=20 Participants
|
7 Participants
n=19 Participants
|
10 Participants
n=39 Participants
|
|
Household income in previous year
$30,000 - 30,999
|
3 Participants
n=20 Participants
|
5 Participants
n=19 Participants
|
8 Participants
n=39 Participants
|
|
Household income in previous year
$40,000 - 59,999
|
4 Participants
n=20 Participants
|
1 Participants
n=19 Participants
|
5 Participants
n=39 Participants
|
|
Household income in previous year
> $60,000
|
3 Participants
n=20 Participants
|
2 Participants
n=19 Participants
|
5 Participants
n=39 Participants
|
|
Household income in previous year
Missing or prefer not to answer
|
2 Participants
n=20 Participants
|
0 Participants
n=19 Participants
|
2 Participants
n=39 Participants
|
|
Number living in household
1-3
|
9 Participants
n=20 Participants
|
6 Participants
n=19 Participants
|
15 Participants
n=39 Participants
|
|
Number living in household
4-6
|
10 Participants
n=20 Participants
|
12 Participants
n=19 Participants
|
22 Participants
n=39 Participants
|
|
Number living in household
7-9
|
1 Participants
n=20 Participants
|
1 Participants
n=19 Participants
|
2 Participants
n=39 Participants
|
|
Personally used herbicides at residence in last year
Yes
|
0 Participants
n=20 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=39 Participants
|
|
Personally used herbicides at residence in last year
No
|
20 Participants
n=20 Participants
|
19 Participants
n=19 Participants
|
39 Participants
n=39 Participants
|
|
Someone else used herbicides at residence in last year
Yes
|
6 Participants
n=20 Participants
|
2 Participants
n=19 Participants
|
8 Participants
n=39 Participants
|
|
Someone else used herbicides at residence in last year
No
|
13 Participants
n=20 Participants
|
15 Participants
n=19 Participants
|
28 Participants
n=39 Participants
|
|
Someone else used herbicides at residence in last year
Don't Know
|
1 Participants
n=20 Participants
|
2 Participants
n=19 Participants
|
3 Participants
n=39 Participants
|
|
Type of herbicides used at residence in last year
Don't know or unknown pesticides sprayed by pesticide control company
|
4 Participants
n=6 Participants • This measure applies only to participants who indicated that they "Personally used herbicides at residence in last year" or "Someone else used herbicides at residence in last year" (i.e., this measure only applies to the 6 participants in the "Organic Diet, Then Conventional Diet" Arm and the 2 participants in the "Conventional Diet, Then Organic Diet" Arm that answered "Yes" to "Personally used herbicides at residence in last year" or "Someone else used herbicides at residence in last year.")
|
1 Participants
n=2 Participants • This measure applies only to participants who indicated that they "Personally used herbicides at residence in last year" or "Someone else used herbicides at residence in last year" (i.e., this measure only applies to the 6 participants in the "Organic Diet, Then Conventional Diet" Arm and the 2 participants in the "Conventional Diet, Then Organic Diet" Arm that answered "Yes" to "Personally used herbicides at residence in last year" or "Someone else used herbicides at residence in last year.")
|
5 Participants
n=8 Participants • This measure applies only to participants who indicated that they "Personally used herbicides at residence in last year" or "Someone else used herbicides at residence in last year" (i.e., this measure only applies to the 6 participants in the "Organic Diet, Then Conventional Diet" Arm and the 2 participants in the "Conventional Diet, Then Organic Diet" Arm that answered "Yes" to "Personally used herbicides at residence in last year" or "Someone else used herbicides at residence in last year.")
|
|
Type of herbicides used at residence in last year
Roundup® (glyphosate)
|
0 Participants
n=6 Participants • This measure applies only to participants who indicated that they "Personally used herbicides at residence in last year" or "Someone else used herbicides at residence in last year" (i.e., this measure only applies to the 6 participants in the "Organic Diet, Then Conventional Diet" Arm and the 2 participants in the "Conventional Diet, Then Organic Diet" Arm that answered "Yes" to "Personally used herbicides at residence in last year" or "Someone else used herbicides at residence in last year.")
|
1 Participants
n=2 Participants • This measure applies only to participants who indicated that they "Personally used herbicides at residence in last year" or "Someone else used herbicides at residence in last year" (i.e., this measure only applies to the 6 participants in the "Organic Diet, Then Conventional Diet" Arm and the 2 participants in the "Conventional Diet, Then Organic Diet" Arm that answered "Yes" to "Personally used herbicides at residence in last year" or "Someone else used herbicides at residence in last year.")
|
1 Participants
n=8 Participants • This measure applies only to participants who indicated that they "Personally used herbicides at residence in last year" or "Someone else used herbicides at residence in last year" (i.e., this measure only applies to the 6 participants in the "Organic Diet, Then Conventional Diet" Arm and the 2 participants in the "Conventional Diet, Then Organic Diet" Arm that answered "Yes" to "Personally used herbicides at residence in last year" or "Someone else used herbicides at residence in last year.")
|
|
Type of herbicides used at residence in last year
Cheetah® (glufosinate ammonium)
|
1 Participants
n=6 Participants • This measure applies only to participants who indicated that they "Personally used herbicides at residence in last year" or "Someone else used herbicides at residence in last year" (i.e., this measure only applies to the 6 participants in the "Organic Diet, Then Conventional Diet" Arm and the 2 participants in the "Conventional Diet, Then Organic Diet" Arm that answered "Yes" to "Personally used herbicides at residence in last year" or "Someone else used herbicides at residence in last year.")
|
0 Participants
n=2 Participants • This measure applies only to participants who indicated that they "Personally used herbicides at residence in last year" or "Someone else used herbicides at residence in last year" (i.e., this measure only applies to the 6 participants in the "Organic Diet, Then Conventional Diet" Arm and the 2 participants in the "Conventional Diet, Then Organic Diet" Arm that answered "Yes" to "Personally used herbicides at residence in last year" or "Someone else used herbicides at residence in last year.")
|
1 Participants
n=8 Participants • This measure applies only to participants who indicated that they "Personally used herbicides at residence in last year" or "Someone else used herbicides at residence in last year" (i.e., this measure only applies to the 6 participants in the "Organic Diet, Then Conventional Diet" Arm and the 2 participants in the "Conventional Diet, Then Organic Diet" Arm that answered "Yes" to "Personally used herbicides at residence in last year" or "Someone else used herbicides at residence in last year.")
|
|
Type of herbicides used at residence in last year
Spectracide® (combination of non-glyphosate herbicides)
|
1 Participants
n=6 Participants • This measure applies only to participants who indicated that they "Personally used herbicides at residence in last year" or "Someone else used herbicides at residence in last year" (i.e., this measure only applies to the 6 participants in the "Organic Diet, Then Conventional Diet" Arm and the 2 participants in the "Conventional Diet, Then Organic Diet" Arm that answered "Yes" to "Personally used herbicides at residence in last year" or "Someone else used herbicides at residence in last year.")
|
0 Participants
n=2 Participants • This measure applies only to participants who indicated that they "Personally used herbicides at residence in last year" or "Someone else used herbicides at residence in last year" (i.e., this measure only applies to the 6 participants in the "Organic Diet, Then Conventional Diet" Arm and the 2 participants in the "Conventional Diet, Then Organic Diet" Arm that answered "Yes" to "Personally used herbicides at residence in last year" or "Someone else used herbicides at residence in last year.")
|
1 Participants
n=8 Participants • This measure applies only to participants who indicated that they "Personally used herbicides at residence in last year" or "Someone else used herbicides at residence in last year" (i.e., this measure only applies to the 6 participants in the "Organic Diet, Then Conventional Diet" Arm and the 2 participants in the "Conventional Diet, Then Organic Diet" Arm that answered "Yes" to "Personally used herbicides at residence in last year" or "Someone else used herbicides at residence in last year.")
|
PRIMARY outcome
Timeframe: One week conventional diet and one week organic dietPopulation: We geocoded each participant's address and verified the existence and location of all fields within a 0.5 km radius of their home. We report specific-gravity adjusted urinary glyphosate concentrations during the conventional and organic weeks for all participants and stratified by agricultural proximity, i.e. for participants living farther than 0.5 km of an agricultural field ("far-field") and living within 0.5 km of an agricultural field ("near-field").
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.
Outcome measures
| Measure |
Conventional Diet
n=78 Composite Urine Samples
This arm refers to participants during their one week assigned to a conventional diet (regardless of whether they were assigned to receive conventional food the first week of the intervention or the second week of the intervention). During this time, participants received a conventional diet for one week. During that week, daily first morning void urine samples were collected.
Participants ordered all food they anticipated eating that week (up to $150) from a unique account with a local grocery store in accordance with a conventional diet (i.e. no organic foods). Study staff verified all food items corresponded with a conventional diet, 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.
|
Organic Diet
n=78 Composite Urine Samples
This arm refers to participants during their one week assigned to an organic diet (regardless of whether they were assigned to receive organic food the first week of the intervention or the second week of the intervention). During this time, participants received an organic diet for one week, defined as food certified through the United States Department of Agriculture National Organic Program as produced without the use of synthetic pesticides, including glyphosate. During that week, daily first morning void urine samples were collected.
Participants ordered all food they anticipated eating that week (up to $150) from a unique account with a local grocery store in accordance with an organic diet. Study staff verified all food items corresponded with an organic diet, 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.
|
|---|---|---|
|
Specific Gravity-adjusted Urinary Glyphosate Concentrations During Conventional and Organic Diet
All Participants
|
0.19 ug/L
Interval 0.11 to 0.3
|
0.17 ug/L
Interval 0.1 to 0.26
|
|
Specific Gravity-adjusted Urinary Glyphosate Concentrations During Conventional and Organic Diet
Far-field Participants
|
0.18 ug/L
Interval 0.11 to 0.31
|
0.14 ug/L
Interval 0.1 to 0.23
|
|
Specific Gravity-adjusted Urinary Glyphosate Concentrations During Conventional and Organic Diet
Near-field Participants
|
0.21 ug/L
Interval 0.12 to 0.29
|
0.20 ug/L
Interval 0.12 to 0.27
|
Adverse Events
Organic Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place