Clinical trial NCT02530814: Organochlorine Pesticide Exposure in Residents Near Lake Apopka
Official title: Organochlorine Pesticide Exposure in Residents Near Lake Apopka
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pesticide Exposure
Keywords: organochlorine compounds
pesticides
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2015-08-21
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants for this study will be recruited from the Florida Farmworker Association of Florida, Lake Apopka, FL.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Persons who worked on farms near lake Apopka, Florida up to 1998.
* Preference will be given to those who worked on the farms for over 10 years.

Exclusion Criteria:

* Persons who did not work on farms near Lake Apopka, Florida up to 1998.

Primary outcomes:
measure: Blood levels of organochlorine pesticides will be compared between the groups
timeFrame: Day 1
Secondary outcomes:
measure: Level of auto-antibodies will be recorded
timeFrame: Day 1
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Margaret O. James, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Eskenazi B, Chevrier J, Rosas LG, Anderson HA, Bornman MS, Bouwman H, Chen A, Cohn BA, de Jager C, Henshel DS, Leipzig F, Leipzig JS, Lorenz EC, Snedeker SM, Stapleton D. The Pine River statement: human health consequences of DDT use. Environ Health Perspect. 2009 Sep;117(9):1359-67. doi: 10.1289/ehp.11748. Epub 2009 May 4.
citation: Xu X, Dailey AB, Talbott EO, Ilacqua VA, Kearney G, Asal NR. Associations of serum concentrations of organochlorine pesticides with breast cancer and prostate cancer in U.S. adults. Environ Health Perspect. 2010 Jan;118(1):60-6. doi: 10.1289/ehp.0900919.
citation: Chhillar N, Singh NK, Banerjee BD, Bala K, Mustafa M, Sharma D, Chhillar M. Organochlorine pesticide levels and risk of Parkinson's disease in north Indian population. ISRN Neurol. 2013 Jul 8;2013:371034. doi: 10.1155/2013/371034. Print 2013.
citation: Wang F, Roberts SM, Butfiloski EJ, Morel L, Sobel ES. Acceleration of autoimmunity by organochlorine pesticides: a comparison of splenic B-cell effects of chlordecone and estradiol in (NZBxNZW)F1 mice. Toxicol Sci. 2007 Sep;99(1):141-52. doi: 10.1093/toxsci/kfm137. Epub 2007 Jun 19.