NCT00015561

Brief Summary

This project is designed to establish whether pesticides or other environmental agents have a role in the excess birth defects identified in the Red River Valley of Minnesota. In this human study, laboratory based health parameters will be used to key in health survey data. In vitro data will be developed to mechanistic information. Concordant results among these study features will provide a weight of evidence approach.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,803

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 1996

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1996

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2001

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2001

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2001

Completed
Last Updated

September 4, 2006

Status Verified

September 1, 2006

First QC Date

April 20, 2001

Last Update Submit

September 1, 2006

Conditions

Birth DefectsMiscarriagesCancer

Keywords

population studieslaboratory evaluationhormone analysissemen analysischromosome studies

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Pesticide applicators and their spouses

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Medical School

Minneapolis, Minnesota, 55414, United States

Location

Related Publications (5)

  • Lyubimov AV, Garry VF, Carlson RE, Barr DB, Baker SE. Simplified urinary immunoassay for 2,4-D: validation and exposure assessment. J Lab Clin Med. 2000 Aug;136(2):116-24. doi: 10.1067/mlc.2000.108150.

    PMID: 10945240BACKGROUND

  • Lin N, Garry VF. In vitro studies of cellular and molecular developmental toxicity of adjuvants, herbicides, and fungicides commonly used in Red River Valley, Minnesota. J Toxicol Environ Health A. 2000 Jul 28;60(6):423-39. doi: 10.1080/00984100050033494.

    PMID: 10933758BACKGROUND

  • Kirkhorn SR, Garry VF. Agricultural lung diseases. Environ Health Perspect. 2000 Aug;108 Suppl 4(Suppl 4):705-12. doi: 10.1289/ehp.00108s4705.

    PMID: 10931789BACKGROUND

  • Garry VF, Burroughs B, Tarone R, Kesner JS. Herbicides and adjuvants: an evolving view. Toxicol Ind Health. 1999 Jan-Mar;15(1-2):159-67. doi: 10.1191/074823399678846619.

    PMID: 10188198BACKGROUND

  • Schreinemachers DM, Creason JP, Garry VF. Cancer mortality in agricultural regions of Minnesota. Environ Health Perspect. 1999 Mar;107(3):205-11. doi: 10.1289/ehp.99107205.

    PMID: 10064550BACKGROUND

MeSH Terms

Conditions

Congenital AbnormalitiesAbortion, SpontaneousNeoplasms

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Vincent F Garry, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
NIH

Study Record Dates

First Submitted

April 20, 2001

First Posted

April 23, 2001

Study Start

September 1, 1996

Study Completion

August 1, 2001

Last Updated

September 4, 2006

Record last verified: 2006-09

Locations

US(1)