- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00341965
Pesticide Exposure and Health Status in North Carolina African American Male Farmers and Farm Workers
August 30, 2019 updated by: National Institute of Environmental Health Sciences (NIEHS)
Pesticide Exposure and Health Status in NC African American Male Farmers and Farm Workers
We propose to conduct a study to increase our understanding of farming practices and of the potential for previous exposure to DDT in North Carolina African American male agricultural workers, a group especially likely to have had high DDT exposure.
Because of potentially widespread DDT exposure from agricultural activities, African American farmers and farm workers may be uniquely at risk for any associated health effects.
However, little is known about levels of pesticide exposure in African American farming populations.
Three hundred and eighty-nine African American men who are current or former farmers or farm workers will be asked to participate in the study.
These men are members of the Supplemental Minority Cohort of the NCI/NIEHS/EPA Agricultural Health Study (AHS).
The AHS is a prospective study of the potential health effects associated with agricultural exposures.
Men in the supplemental cohort were recruited in 1996.
At that time, they completed an enrollment questionnaire that focused on lifetime agricultural exposures, demographics, lifestyle factors and health.
In this new study, a follow-up questionnaire will be administered by telephone by a trained interviewer to all men.
Following the interview, the participant will be asked to donate a blood specimen, to have anthropometric indices (e.g., height, weight, waist and hip circumference, etc.) measured, and to have a top- and side view Polaroid photograph of their head taken during one visit to a central community location, such as the local church or health clinic.
We will quantitatively document serum p,p'-DDE levels, correlate these with self-reported farming activities and DDT exposure, and describe the health status of these men.
We will also correlate serum p,p'-DDE levels and androgen concentrations, since p,p'-DDE is thought to be a potent androgen receptor antagonist.
This exploration of the potential link between levels is important because the demonstration of any subclinical physiological effects of p,p'-DDE would increase the plausibility of a wide range of health effects that have been postulated to be associated with the endogenous endocrine environment and the so-called endocrine disrupters.
In addition, we will evaluate the relationship between several important physiological parameters which can be easily and accurately measured in serum, and physical characteristics including hair patterning and distribution of body fat in these African American men.
Study Overview
Status
Completed
Conditions
Detailed Description
We propose to conduct a study to increase our understanding of farming practices and of the potential for previous exposure to DDT in North Carolina African American male agricultural workers, a group especially likely to have had high DDT exposure.
Because of potentially widespread DDT exposure from agricultural activities, African American farmers and farm workers may be uniquely at risk for any associated health effects.
However, little is known about levels of pesticide exposure in African American farming populations.
Three hundred and eighty-nine African American men who are current or former farmers or farm workers will be asked to participate in the study.
These men are members of the Supplemental Minority Cohort of the NCI/NIEHS/EPA Agricultural Health Study (AHS).
The AHS is a prospective study of the potential health effects associated with agricultural exposures.
Men in the supplemental cohort were recruited in 1996.
At that time, they completed an enrollment questionnaire that focused on lifetime agricultural exposures, demographics, lifestyle factors and health.
In this new study, a follow-up questionnaire will be administered by telephone by a trained interviewer to all men.
Following the interview, the participant will be asked to donate a blood specimen, to have anthropometric indices (e.g., height, weight, waist and hip circumference, etc.) measured, and to have a top- and side view Polaroid photograph of their head taken during one visit to a central community location, such as the local church or health clinic.
We will quantitatively document serum p,p'-DDE levels, correlate these with self-reported farming activities and DDT exposure, and describe the health status of these men.
We will also correlate serum p,p'-DDE levels and androgen concentrations, since p,p'-DDE is thought to be a potent androgen receptor antagonist.
This exploration of the potential link between levels is important because the demonstration of any subclinical physiological effects of p,p'-DDE would increase the plausibility of a wide range of health effects that have been postulated to be associated with the endogenous endocrine environment and the so-called endocrine disrupters.
In addition, we will evaluate the relationship between several important physiological parameters which can be easily and accurately measured in serum, and physical characteristics including hair patterning and distribution of body fat in these African American men.
Study Type
Observational
Enrollment (Actual)
275
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
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North Carolina
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Research Triangle Park, North Carolina, United States, 27709
- NIEHS, Research Triangle Park
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
- INCLUSION CRITERIA:
All African American men who are members of the Supplemental Minority Cohort of the NCI/NIEHS/EPA Agricultural Health Study will be recontacted and asked to participate in the study.
EXCLUSION CRITERIA:
We are limiting this initial study to adult African American males.
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?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
- Bagatell CJ, Bremner WJ. Androgens in men--uses and abuses. N Engl J Med. 1996 Mar 14;334(11):707-14. doi: 10.1056/NEJM199603143341107. No abstract available.
- Alavanja MC, Sandler DP, McMaster SB, Zahm SH, McDonnell CJ, Lynch CF, Pennybacker M, Rothman N, Dosemeci M, Bond AE, Blair A. The Agricultural Health Study. Environ Health Perspect. 1996 Apr;104(4):362-9. doi: 10.1289/ehp.96104362. Erratum In: Environ Health Perspect.1996 Jul;104(7):683.
- Austin SG, Huang N, Woernle CW. PMR study of mortality among Alabama workers and farmers. Am J Ind Med. 1995 Jan;27(1):29-36. doi: 10.1002/ajim.4700270104.
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
January 27, 1999
Study Completion
November 4, 2013
Study Registration Dates
First Submitted
June 19, 2006
First Submitted That Met QC Criteria
June 19, 2006
First Posted (Estimate)
June 21, 2006
Study Record Updates
Last Update Posted (Actual)
September 3, 2019
Last Update Submitted That Met QC Criteria
August 30, 2019
Last Verified
November 4, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 999999006
- OH99-E-N006
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.