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CompletedNCT00341965Updated Sep 3, 2019

Pesticide Exposure and Health Status in North Carolina African American Male Farmers and Farm Workers

An observational study in Pesticide Exposure, sponsored by National Institute of Environmental Health Sciences (NIEHS). Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-03.

Sponsored by National Institute of Environmental Health Sciences (NIEHS) · Observational

Study type
Observational
Enrollment
275
Ages
18 Years and older
Sex
Male
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Pesticide Exposure

Keywords

  • DDT
  • DDE
  • Androgen Levels
  • Farming
  • Antiandrogen
03

In context

Lead sponsor

National Institute of Environmental Health Sciences (NIEHS) is the lead sponsor of 175 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

EXCLUSION CRITERIA:

We are limiting this initial study to adult African American males.

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Study design

Enrollment
275 participants (actual)
06

Study locations

1 site
  • NIEHS, Research Triangle Park
    Research Triangle Park, North Carolina 27709, United States
07

References and documents

Publications

  • 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. PubMed 8732939 ↗
  • 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. PubMed 8594431 ↗
  • 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. PubMed 7900733 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00341965
Lead sponsor
National Institute of Environmental Health Sciences (NIEHS)
First posted
Jun 21, 2006
Start date
Jan 27, 1999
Completion
Nov 4, 2013
Last update
Sep 3, 2019

Study contacts

Dale Sandler, Ph.D.
principal investigator · National Institute of Environmental Health Sciences (NIEHS)
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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