Organochlorine Pesticide Exposure in Residents Near Lake Apopka

September 17, 2019 updated by: University of Florida

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood levels of organochlorine pesticides will be compared between the groups
Time Frame: 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.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of auto-antibodies will be recorded
Time Frame: Day 1
Blood collected will be analyzed for measurement of auto-antibodies
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

August 18, 2015

First Submitted That Met QC Criteria

August 19, 2015

First Posted (Estimate)

August 21, 2015

Study Record Updates

Last Update Posted (Actual)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB201401073

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Age and years worked on farms will be shared

IPD Sharing Time Frame

Will be reported in publication, in preparation.

IPD Sharing Access Criteria

upon request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pesticide Exposure

Clinical Trials on Blood Collection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe