Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03049527 |
| Other study ID # |
16-1824 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2017 |
| Est. completion date |
April 27, 2017 |
Study information
| Verified date |
June 2021 |
| Source |
University of Colorado, Denver |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The objective of this research project is to investigate specific behaviors and exposures
related to sugarcane work and their association with non-communicable diseases, specifically
Chronic Kidney Disease of Unknown Origin (CKDu) among sugarcane workers in Guatemala. Over
the course of the 6-month sugarcane harvest the investigators will assess risk factors for
declining kidney function, and also changes in biomarkers of kidney function pre and post
work shift of field and factory workers and their possible relationships with dehydration and
heat stress. The investigators will also evaluate the effectiveness of an intervention aimed
at increasing hydration and reducing heat stress. Finally the investigators will measure
biomarkers of exposure and environmental samples for heavy metals, agrochemicals, and
infectious disease (Leptospira).
Description:
This protocol describes two prospective cohort studies and one intervention study that will
be conducted throughout the sugarcane harvest, from October through May, at Pantaleon's
sugarcane plantations in Guatemala.
Overview of Studies
The investigators propose to conduct the three studies by making use of existing
pre-employment data from prior years and by collecting new data during the 6-month sugarcane
harvest. Pre-employment data are collected for all workers (N=5000) by Pantaleon and
screenings occur throughout the harvest. Pre-employment and screening data include
information on demographics, behaviors, work practices, non-communicable diseases, including
kidney disease.
The purpose of the three new studies will be to collect detailed data on risk factors and
biomarkers for CKDu. Risk factors will be assessed by collecting information through surveys
and medical exams, and by collecting biological samples (blood and urine) from a subsample of
the workers.
Study 1) Natural History of CKDu Study
Study Rationale: This study will prospectively follow a cohort of sugarcane workers (N=407)
over multiple years to understand the natural history of CKDu. By following this cohort of
workers, we will be able to describe the prevalence and incidence of abnormal eGFR and
identify risk factors for CKDu.
Study Design and Populations: Pantaleon conducted a post-harvest evaluation of 407 workers
following the 2015-2016 harvest. The investigators will conduct a prospective longitudinal
study of this established cohort of workers (recruited during the end of the 2015-16 harvest)
and will work with Pantaleon to replicate this post-harvest evaluation at the end of the
2016-2017 harvest.
Study 2) Industrial Mill Worker Observational Study
Study Rationale: This study will prospectively follow a stratified random selection of 100
mill workers throughout the harvest to understand the prevalence and incidence of kidney
damage. The investigators will be able to describe the prevalence and incidence of abnormal
eGFR and identify risk factors for CKDu. Although mill workers are indoors, we have
informally observed that some of them work under conditions of high heat, placing them at
risk for heat stress, dehydration and possibly CKDu.
Study Design and Population: Occupational Health and Safety staff at Pantaleon have
identified job descriptions associated with heat exposure in the mill. Pantaleon will conduct
pre-employment evaluations among 100 mill workers, specifically selecting a random sample of
workers with job titles associated with high heat. At the end of the harvest, the
investigators will collect occupational and non-occupational risk factors through a survey
and medical exam and measure creatinine levels through a blood finger prick among the 100
mill workers.
Study 3) Hydration Study
Study Rationale: This study will prospectively assess acute and chronic kidney damage among
sugarcane workers by evaluating kidney function a) before the start of the harvest and at the
end of the harvest, and b) before and after work shifts during the harvest. An intervention
will be implemented aimed at increasing hydration and reducing heat stress among sugarcane
workers throughout the day. The investigators will assess the effectiveness of this
intervention in increasing hydration and work productivity, with the final goal of the
intervention aimed at decreasing acute and chronic kidney damage.
Study Design and Population: This study will comprise of the following: 1) implementation of
an intervention which will include a wellness incentive and enhanced education on heat stress
and hydration, and 2) investigation of biological markers of dehydration and acute kidney
injury among approximately 500 sugarcane workers. Workers will be recruited from 10 work
groups randomly selected at the Pantaleon work site. Each group will have data collected 3
times during the 6-month harvest.
Sub-Study 3.1) Heat Sub-study
Study Rational: This sub-study will increase understanding of the physiological response of
workers to heat exposure and determine the workers' metabolic workload. The investigators
will be able to examine across shift changes of physiological responses and its effects on
acute and chronic kidney function. It will help determine if workers are receiving sufficient
duration and number of rest periods.
Study Design and Population: Among the participants of the Hydration study, 100 workers will
be randomly selected to participate in the Heat study. Data for this study will be collected
during 3 periods of the Hydration Study (November, January, and March). When each Heat
Sub-study participant is having data collected for the Hydration Study, the investigators
will collect this additional information for that participant.
