Birth DefectsNCT00015561
Pesticides--Health Fertility and Reproductive Risk
An observational study of Birth Defects and Miscarriages, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Birth Defects, Miscarriages, Cancer
- How many people
- 1,803 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1996to Aug 2001
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Pesticide applicators and their spouses
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical School
Minneapolis, Minnesota, 55414
About this study
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.
- Conditions
- Birth Defects, Miscarriages, Cancer
- Keywords
- population studies, laboratory evaluation, hormone analysis, semen analysis, chromosome studies
- Medical subject headings
- Congenital Abnormalities, Abortion, Spontaneous, Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2001 (estimated)
- Study startSep 1996
- Study completionAug 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Birth DefectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 1,803 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Investigators
- Vincent F Garry, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00015561
- Sponsor's protocol ID
- 8161-CP-001
- Status last verified
- Sep 2006
- First submitted
- 20 Apr 2001
- Last updated
- 4 Sep 2006
- Results posted
- No
Publications
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.
PubMed 10945240Lin 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.
PubMed 10933758Kirkhorn SR, Garry VF. Agricultural lung diseases. Environ Health Perspect. 2000 Aug;108 Suppl 4(Suppl 4):705-12. doi: 10.1289/ehp.00108s4705.
PubMed 10931789Garry 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.
PubMed 10188198Schreinemachers 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.
PubMed 10064550
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pesticides--Health Fertility and Reproductive Risk
- ClinicalTrials.gov ID
- NCT00015561
- Acronym / sponsor ID
- 8161-CP-001
- Conditions
- Birth Defects, Miscarriages, Cancer
- Keywords
- population studies, laboratory evaluation, hormone analysis, semen analysis, chromosome studies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,803 participants
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- Sep 1996
- Study completion
- Aug 2001
- First posted
- 23 Apr 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2006.
- Background: PubMed 10945240Lyubimov 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.
- Background: PubMed 10933758Lin 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.
- Background: PubMed 10931789Kirkhorn SR, Garry VF. Agricultural lung diseases. Environ Health Perspect. 2000 Aug;108 Suppl 4(Suppl 4):705-12. doi: 10.1289/ehp.00108s4705.
- Background: PubMed 10188198Garry 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.
- Background: PubMed 10064550Schreinemachers 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent F Garry, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Birth Defects and Miscarriages, 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?
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 4 Sep 2006. 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 NCT00015561, which also lists 5 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 4 Sep 2006.