Organochlorine Pesticide Exposure in Residents Near Lake Apopka

Pesticide Exposure Clinical Trial

Official title:

Organochlorine Pesticide Exposure in Residents Near Lake Apopka

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02530814
• Other study ID #: IRB201401073
• Status: Completed
• Start date: November 2015
• Est. completion date: March 2016

Study information

• Verified date: September 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pesticide Exposure

Intervention

Other:
• Blood Collection
Onetime blood collection.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (5)

Beard J; Australian Rural Health Research Collaboration. DDT and human health. Sci Total Environ. 2006 Feb 15;355(1-3):78-89. Review. — View 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. — View 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. Review. — View 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. Epub 2007 Jun 19. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1
Secondary	Level of auto-antibodies will be recorded	Blood collected will be analyzed for measurement of auto-antibodies	Day 1