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Pesticide ExposureNCT00341965

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

An observational study of Pesticide Exposure, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Pesticide Exposure
How many people
275 participants
Where
1 siteUnited States
Study dates
27 Jan 1999to 4 Nov 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • NIEHS, Research Triangle Park

    Research Triangle Park, North Carolina, 27709

Other trials in United States

About this study

Official title: 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.

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.

Keywords
DDT, DDE, Androgen Levels, Farming, Antiandrogen

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2006 (estimated)
  2. Study start27 Jan 1999
  3. Study completion4 Nov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
275 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00341965
Sponsor's protocol ID
999999006
Other IDs
OH99-E-N006
Status last verified
4 Nov 2013
First submitted
19 Jun 2006
Last updated
3 Sep 2019
Results posted
No

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.

    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

Questions about this trial

What is this clinical trial studying?

An observational study of Pesticide Exposure, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00341965, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2019.

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