- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00341965
Pesticide Exposure and Health Status in North Carolina African American Male Farmers and Farm Workers
30. August 2019 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
275
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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North Carolina
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Research Triangle Park, North Carolina, Vereinigte Staaten, 27709
- NIEHS, Research Triangle Park
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Männlich
Beschreibung
- 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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
27. Januar 1999
Studienabschluss
4. November 2013
Studienanmeldedaten
Zuerst eingereicht
19. Juni 2006
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
19. Juni 2006
Zuerst gepostet (Schätzen)
21. Juni 2006
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
3. September 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
30. August 2019
Zuletzt verifiziert
4. November 2013
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 999999006
- OH99-E-N006
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