Understanding Occupational and Non-occupational Risks Associated With CKDu in Sugarcane Workers in Guatemala
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 531
- 试验地点
- 2
- 主要终点
- Change in Abnormal Glomerular Filtration Rate (eGFR)
研究概览
简要总结
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).
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •currently employed by Pantaleon
- •age 18 or older.
排除标准
- •pregnant women
研究组 & 干预措施
Education, Incentives and Feedback
Education, Incentives and Feedback are all directed to all study participants.
干预措施: Education, Incentives and Feedback (Behavioral)
结局指标
主要结局
Change in Abnormal Glomerular Filtration Rate (eGFR)
时间窗: Day 0 then every 4 weeks for 8 weeks
Calculated from serum creatinine levels measured in blood samples. Abnormal eGFR is defined as an eGFR of \<60 ml/min/1.73 m2. Serum creatinine will be used to calculate eGFR using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation for all participants. Lower eGFR and higher serum creatinine levels indicate worse kidney function.
次要结局
- Change in Prevalence of Workplace Injuries and Illnesses(Week 1 and 6 months)
- Change in Productivity(Over the 6 month harvest period)