Pesticide ExposureNCT02530814
Organochlorine Pesticide Exposure in Residents Near Lake Apopka
An observational study of Pesticide Exposure, run by University of Florida at 1 site in United States.
Trial summary
In the Lake Apopka, Florida area for over 50 years starting in the 1940s, organochlorine pesticides (OCPs) including 4,4'-dichlorodiphenyltrichloroethane (DDT), dieldrin, chlordane, toxaphene and more recently methoxychlor were sprayed on farmlands in order to control pests and to improve crop harvests. Read more about this study
- Who is it for?
- Ages 21 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Pesticide Exposure
- What is being tested?
- Blood Collection
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Mar 2016
- 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 21 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants for this study will be recruited from the Florida Farmworker Association of Florida, Lake Apopka, FL.
Who may be able to join
- Persons who worked on farms near lake Apopka, Florida up to 1998.
- Preference will be given to those who worked on the farms for over 10 years.
Who cannot join
- Persons who did not work on farms near Lake Apopka, Florida up to 1998.
Trial locations and contacts
1 site in 1 country.
About this study
In the Lake Apopka, Florida area for over 50 years starting in the 1940s, organochlorine pesticides (OCPs) including 4,4'-dichlorodiphenyltrichloroethane (DDT), dieldrin, chlordane, toxaphene and more recently methoxychlor were sprayed on farmlands in order to control pests and to improve crop harvests. For most of those years, the farmworkers were exposed to the pesticides as part of their work. Because of their lipophilic (fat soluble) nature, these organochlorine pesticides (OCPs) are readily taken up into the body and not readily eliminated. Therefore, they can be detected in exposed individuals for many years after the exposure. There is some evidence that certain OCPs can cause or exacerbate medical problems in sensitive individuals. For example, exposure to some OCPs has been associated with development of Parkinsonism. Exposure to other OCPs has been associated with development of lupus erythematosus, an auto-immune disease. Other adverse effects of exposure to OCPs are endocrine disruption because some OCPs mimic estrogens and others mimic androgens, or may have mixed interactions with steroid receptors.
In this research study the investigators aim is to test the blood from former farmworkers during the 1940s through the late 1970s who reside in the Lake Apopka area for OCPs and for the auto-antibodies. In addition, questionnaires will provide insight on their health status and health concerns.
Read the detailed description
In this research study, a onetime blood test will be collected from former farmworkers during the 1940s through the late 1970s who reside in the Lake Apopka area for OCPs and for the auto-antibodies. In addition, questionnaires will provide insight on their health status and health concerns.
The investigators will collect existing data from the National Health and Nutrition Examination Survey (NHANES) which has monitored the pesticide exposure (with the exception of toxaphene) of people older than 8 years, so there is information on the range of concentrations of these chemicals in the blood of Americans. This data will be use as the control group for comparison with the values found for OCP concentrations.
- Conditions
- Pesticide Exposure
- Being tested
- Blood Collection
- Keywords
- organochlorine compounds, pesticides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood CollectionOther
Onetime blood collection.
| Study group | Role | What they receive |
|---|---|---|
| Lake Apopka Farmworkers | This group will have a onetime blood collection and questionnaires regarding health status and health concerns. Receives: Other: Blood Collection | |
| Existing Data Group | The investigators will collect existing data from the National Health and Nutrition Examination Survey (NHANES) for the range of concentrations of these chemicals in the blood of Americans. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood levels of organochlorine pesticides will be compared between the groups
Blood collected will be analyzed for DDT, dieldrin, chlordane, methoxychlor and the metabolites of DDT and methoxychlor. The data will be compared between the groups.
Measured: Day 1
Secondary outcomes (1)
Level of auto-antibodies will be recorded
Blood collected will be analyzed for measurement of auto-antibodies
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study startNov 2015
- Primary completionMar 2016
- Study completionMar 2016
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 Pesticide ExposureStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margaret O. James, Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530814
- Sponsor's protocol ID
- IRB201401073
- Status last verified
- Sep 2019
- First submitted
- 18 Aug 2015
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Age and years worked on farms will be shared
Publications
Beard J; Australian Rural Health Research Collaboration. DDT and human health. Sci Total Environ. 2006 Feb 15;355(1-3):78-89. doi: 10.1016/j.scitotenv.2005.02.022.
PubMed 15894351Eskenazi B, Chevrier J, Rosas LG, Anderson HA, Bornman MS, Bouwman H, Chen A, Cohn BA, de Jager C, Henshel DS, Leipzig F, Leipzig JS, Lorenz EC, Snedeker SM, Stapleton D. The Pine River statement: human health consequences of DDT use. Environ Health Perspect. 2009 Sep;117(9):1359-67. doi: 10.1289/ehp.11748. Epub 2009 May 4.
PubMed 19750098Xu X, Dailey AB, Talbott EO, Ilacqua VA, Kearney G, Asal NR. Associations of serum concentrations of organochlorine pesticides with breast cancer and prostate cancer in U.S. adults. Environ Health Perspect. 2010 Jan;118(1):60-6. doi: 10.1289/ehp.0900919.
PubMed 20056587Chhillar N, Singh NK, Banerjee BD, Bala K, Mustafa M, Sharma D, Chhillar M. Organochlorine pesticide levels and risk of Parkinson's disease in north Indian population. ISRN Neurol. 2013 Jul 8;2013:371034. doi: 10.1155/2013/371034. Print 2013.
PubMed 23936670Wang F, Roberts SM, Butfiloski EJ, Morel L, Sobel ES. Acceleration of autoimmunity by organochlorine pesticides: a comparison of splenic B-cell effects of chlordecone and estradiol in (NZBxNZW)F1 mice. Toxicol Sci. 2007 Sep;99(1):141-52. doi: 10.1093/toxsci/kfm137. Epub 2007 Jun 19.
PubMed 17578864
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organochlorine Pesticide Exposure in Residents Near Lake Apopka
- ClinicalTrials.gov ID
- NCT02530814
- Acronym / sponsor ID
- IRB201401073
- Conditions
- Pesticide Exposure
- Keywords
- organochlorine compounds, pesticides
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 21 Aug 2015 (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.
In the Lake Apopka, Florida area for over 50 years starting in the 1940s, organochlorine pesticides (OCPs) including 4,4'-dichlorodiphenyltrichloroethane (DDT), dieldrin, chlordane, toxaphene and more recently methoxychlor were sprayed on farmlands in order to control pests and to improve crop harvests. For most of those years, the farmworkers were exposed to the pesticides as part of their work. Because of their lipophilic (fat soluble) nature, these organochlorine pesticides (OCPs) are readily taken up into the body and not readily eliminated. Therefore, they can be detected in exposed individuals for many years after the exposure. There is some evidence that certain OCPs can cause or exacerbate medical problems in sensitive individuals. For example, exposure to some OCPs has been associated with development of Parkinsonism. Exposure to other OCPs has been associated with development of lupus erythematosus, an auto-immune disease. Other adverse effects of exposure to OCPs are endocrine disruption because some OCPs mimic estrogens and others mimic androgens, or may have mixed interactions with steroid receptors.
In this research study the investigators aim is to test the blood from former farmworkers during the 1940s through the late 1970s who reside in the Lake Apopka area for OCPs and for the auto-antibodies. In addition, questionnaires will provide insight on their health status and health concerns.
Detailed description
In this research study, a onetime blood test will be collected from former farmworkers during the 1940s through the late 1970s who reside in the Lake Apopka area for OCPs and for the auto-antibodies. In addition, questionnaires will provide insight on their health status and health concerns.
The investigators will collect existing data from the National Health and Nutrition Examination Survey (NHANES) which has monitored the pesticide exposure (with the exception of toxaphene) of people older than 8 years, so there is information on the range of concentrations of these chemicals in the blood of Americans. This data will be use as the control group for comparison with the values found for OCP concentrations.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lake Apopka Farmworkers | – | Other: Blood CollectionThis group will have a onetime blood collection and questionnaires regarding health status and health concerns. |
| Existing Data Group | – | –The investigators will collect existing data from the National Health and Nutrition Examination Survey (NHANES) for the range of concentrations of these chemicals in the blood of Americans. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants for this study will be recruited from the Florida Farmworker Association of Florida, Lake Apopka, FL.
Key inclusion criteria (2 listed)
- Persons who worked on farms near lake Apopka, Florida up to 1998.
- Preference will be given to those who worked on the farms for over 10 years.
Key exclusion criteria (1 listed)
- Persons who did not work on farms near Lake Apopka, Florida up to 1998.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood CollectionOnetime blood collection. | Other | Lake Apopka Farmworkers |
Primary outcome
Blood levels of organochlorine pesticides will be compared between the groups
Time frame: Day 1
Blood collected will be analyzed for DDT, dieldrin, chlordane, methoxychlor and the metabolites of DDT and methoxychlor. The data will be compared between the groups.
1 secondary outcome
Level of auto-antibodies will be recorded
Time frame: Day 1
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 19 Sep 2019.
- Background: PubMed 15894351Beard J; Australian Rural Health Research Collaboration. DDT and human health. Sci Total Environ. 2006 Feb 15;355(1-3):78-89. doi: 10.1016/j.scitotenv.2005.02.022.
- Background: PubMed 19750098Eskenazi B, Chevrier J, Rosas LG, Anderson HA, Bornman MS, Bouwman H, Chen A, Cohn BA, de Jager C, Henshel DS, Leipzig F, Leipzig JS, Lorenz EC, Snedeker SM, Stapleton D. The Pine River statement: human health consequences of DDT use. Environ Health Perspect. 2009 Sep;117(9):1359-67. doi: 10.1289/ehp.11748. Epub 2009 May 4.
- Background: PubMed 20056587Xu X, Dailey AB, Talbott EO, Ilacqua VA, Kearney G, Asal NR. Associations of serum concentrations of organochlorine pesticides with breast cancer and prostate cancer in U.S. adults. Environ Health Perspect. 2010 Jan;118(1):60-6. doi: 10.1289/ehp.0900919.
- Background: PubMed 23936670Chhillar N, Singh NK, Banerjee BD, Bala K, Mustafa M, Sharma D, Chhillar M. Organochlorine pesticide levels and risk of Parkinson's disease in north Indian population. ISRN Neurol. 2013 Jul 8;2013:371034. doi: 10.1155/2013/371034. Print 2013.
- Background: PubMed 17578864Wang F, Roberts SM, Butfiloski EJ, Morel L, Sobel ES. Acceleration of autoimmunity by organochlorine pesticides: a comparison of splenic B-cell effects of chlordecone and estradiol in (NZBxNZW)F1 mice. Toxicol Sci. 2007 Sep;99(1):141-52. doi: 10.1093/toxsci/kfm137. Epub 2007 Jun 19.
- Individual participant dataSharing planned: Yes. Age and years worked on farms will be shared
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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.
Margaret O. James, Ph.D. principal investigator
University of Florida
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 Pesticide Exposure, run by University of Florida 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 2 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 19 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.
What does the primary outcome measure?
Blood levels of organochlorine pesticides will be compared between the groups (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02530814, 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 19 Sep 2019.