An observational study in Pesticide Exposure, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 21 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-19.
Sponsored by University of Florida · Observational
In the Lake Apopka, Florida area for over 50 years starting in the 1940s, organochlorine pesticides (OCPs) including 4,4'-dichlorodiphenyltrichloroethane (DDT), dieldrin, chlordane, toxaphene and more recently methoxychlor were sprayed on farmlands in order to control pests and to improve crop harvests. For most of those years, the farmworkers were exposed to the pesticides as part of their work. Because of their lipophilic (fat soluble) nature, these organochlorine pesticides (OCPs) are readily taken up into the body and not readily eliminated. Therefore, they can be detected in exposed individuals for many years after the exposure. There is some evidence that certain OCPs can cause or exacerbate medical problems in sensitive individuals. For example, exposure to some OCPs has been associated with development of Parkinsonism. Exposure to other OCPs has been associated with development of lupus erythematosus, an auto-immune disease. Other adverse effects of exposure to OCPs are endocrine disruption because some OCPs mimic estrogens and others mimic androgens, or may have mixed interactions with steroid receptors.
In this research study the investigators aim is to test the blood from former farmworkers during the 1940s through the late 1970s who reside in the Lake Apopka area for OCPs and for the auto-antibodies. In addition, questionnaires will provide insight on their health status and health concerns.
In this research study, a onetime blood test will be collected from former farmworkers during the 1940s through the late 1970s who reside in the Lake Apopka area for OCPs and for the auto-antibodies. In addition, questionnaires will provide insight on their health status and health concerns.
The investigators will collect existing data from the National Health and Nutrition Examination Survey (NHANES) which has monitored the pesticide exposure (with the exception of toxaphene) of people older than 8 years, so there is information on the range of concentrations of these chemicals in the blood of Americans. This data will be use as the control group for comparison with the values found for OCP concentrations.
University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
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Participants for this study will be recruited from the Florida Farmworker Association of Florida, Lake Apopka, FL.
Exclusion Criteria:
This group will have a onetime blood collection and questionnaires regarding health status and health concerns.
Other: Blood Collection
The investigators will collect existing data from the National Health and Nutrition Examination Survey (NHANES) for the range of concentrations of these chemicals in the blood of Americans.
Onetime blood collection.
Blood levels of organochlorine pesticides will be compared between the groups
Blood collected will be analyzed for DDT, dieldrin, chlordane, methoxychlor and the metabolites of DDT and methoxychlor. The data will be compared between the groups.
Time frame: Day 1
Level of auto-antibodies will be recorded
Blood collected will be analyzed for measurement of auto-antibodies
Time frame: Day 1
Plan to share: Yes — Age and years worked on farms will be shared
Supporting information: Study protocol, Icf
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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