Organochlorine Pesticide Exposure in Residents Near Lake Apopka

Sponsor
University of Florida (Other)
Overall Status
Completed
CT.gov ID
NCT02530814
Collaborator
(none)
20
1
4
5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Blood Collection

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.

Study Design

Study Type:
Observational
Actual Enrollment :
20 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Organochlorine Pesticide Exposure in Residents Near Lake Apopka
Study Start Date :
Nov 1, 2015
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Lake Apopka Farmworkers

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

Other: Blood Collection
Onetime 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.

Outcome Measures

Primary Outcome Measures

  1. Blood levels of organochlorine pesticides will be compared between the groups [Day 1]

    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.

Secondary Outcome Measures

  1. Level of auto-antibodies will be recorded [Day 1]

    Blood collected will be analyzed for measurement of auto-antibodies

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Florida Gainesville Florida United States 32611

Sponsors and Collaborators

  • University of Florida

Investigators

  • Principal Investigator: Margaret O. James, Ph.D., University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Florida
ClinicalTrials.gov Identifier:
NCT02530814
Other Study ID Numbers:
  • IRB201401073
First Posted:
Aug 21, 2015
Last Update Posted:
Sep 19, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by University of Florida

Study Results

No Results Posted as of Sep 19, 2019