Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04155463 |
Other study ID # |
K01ES028745 |
Secondary ID |
K01ES028745 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 23, 2021 |
Est. completion date |
December 28, 2021 |
Study information
Verified date |
April 2023 |
Source |
Boise State University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
This study focuses on human exposure to glyphosate, the single most commonly applied
agricultural chemical in the world. Glyphosate is an herbicide, and is most commonly known as
the active ingredient in "Round Up". Glyphosate has been declared a probable human carcinogen
by the International Agency for Research on Cancer and multiple toxicological studies have
further suggested potential neurological and developmental effects of glyphosate exposure at
environmentally-relevant levels. However, despite its extensive use, frequent presence in
food and environmental media, and potential toxicity, current exposure levels in human
populations are not well documented. This study aims to assess glyphosate exposure among a
cohort of pregnant women and to quantify the relative contribution of agricultural and
dietary sources of this exposure. A cohort of 40 pregnant women will be recruited from urban
areas >10 miles from the nearest glyphosate-treated field and agricultural areas <1 mile from
the nearest glyphosate-treated field. Weekly urine samples collected from these women
throughout their pregnancies will be used to analyze glyphosate exposure. These same 40
participants will also take part in a two week-long randomized cross-over design dietary
intervention, during which participants will receive one week of exclusively organic food
(grown without the use of synthetic pesticides, including glyphosate) and one week of
exclusively conventional food, in random order. During the intervention, the researchers will
collect daily spot urine samples from each participant to analyze glyphosate exposure related
to diet. The researchers hypothesize that during the time of year when glyphosate is actively
applied, women living near glyphosate-treated fields will have higher exposures than those
living further away. They also hypothesize that glyphosate exposure will be reduced among
participants during randomization to the organic diet, but that this decrease will be larger
among urban women than among those living near glyphosate-treated fields. The researchers
have taken extra precautions to eliminate all COVID-specific risks. There will be no
face-to-face contact between research staff and study participants throughout the entire
study. Interactions between researchers and study participants will take place through
videos, emails, texts, and/or phone calls. All urine samples will be left for researchers to
pick up at a predetermined location and time, and all groceries will be delivered to
participants' home and left at their front door.