CKDu in Sugarcane Workers in Guatemala

NCT03049527 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 531

Last updated 2021-06-23

No results posted yet for this study

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).

Conditions

Interventions

BEHAVIORAL

Education, Incentives and Feedback

The study participants will receive additional educational activities, including low-literacy fact sheets on liquid intake guidelines, cards with instructions on how to self-monitor urine color and volume, and flyers and posters placed throughout the worksite. All consenting study participants will be offered incentives to start the work day hydrated and then to maintain or improve their hydration status over the work shift. Participants who do not meet hydration goals will receive additional coaching and feedback on ways to improve hydration.Feedback will also be provided to all groups about their productivity level to help participants recognize the connection between improved health and function.

Sponsors & Collaborators

  • Pantaleon

    collaborator OTHER
  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Lee Newman, MD · University of Colorado, Denver

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2017-04-27
Completion
2017-04-27

Countries

  • United States
  • Guatemala

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03049527 on ClinicalTrials.gov