Organochlorine Pesticide Exposure in Residents Near Lake Apopka

NCT02530814 | Completed DMC

• 1 other identifier: IRB201401073
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pesticide Exposure

Keywords

organochlorine compounds; pesticides

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Level of auto-antibodies will be recorded

  Day 1

Study Arms (2)

Lake Apopka Farmworkers

This group will have a onetime blood collection and questionnaires regarding health status and health concerns.

Other: Blood Collection

Existing Data Group

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.

Interventions

Blood Collection OTHER

Onetime blood collection.

Lake Apopka Farmworkers

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants for this study will be recruited from the Florida Farmworker Association of Florida, Lake Apopka, FL.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (5)

• Beard J; Australian Rural Health Research Collaboration. DDT and human health. Sci Total Environ. 2006 Feb 15;355(1-3):78-89. doi: 10.1016/j.scitotenv.2005.02.022.

  PMID: 15894351 BACKGROUND

• 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.

  PMID: 19750098 BACKGROUND

• 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.

  PMID: 20056587 BACKGROUND

• 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.

  PMID: 23936670 BACKGROUND

• 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.

  PMID: 17578864 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected for analysis of organochlorine pesticides and auto-antibodies.

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Margaret O. James, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: August 21, 2015
• Study Start: November 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Will be reported in publication, in preparation.
• Access Criteria: upon request

Locations

US (1)