Peripheral NeuropathyNCT00671866
Neurotoxic Health Hazards of Long-Term Low-Level Exposure to Organophosphate (OP) Compounds in in Hula Valley
An observational study of Peripheral Neuropathy, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
During 1987-1991, WHO supported studies of exposures and short term neurobehavioral effects in a cohort (n=200) with occupational and community exposures to pesticide drift containing organophosphates from orchards and cotton fields in the Hula Valley. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Peripheral Neuropathy
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Residents of Kibbutzim
Who may be able to join
- Participants of the former study twenty years ago
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Neurology and Toxicology Unit and Service, Shaare Zedek Med Ctr
Jerusalem, 91031
Yoram Finkelstein, MD PhD, 972-2-6555655, yoramf@ekmd.huji.ac.il
Yoram Finkelstein, MD PhD
About this study
During 1987-1991, WHO supported studies of exposures and short term neurobehavioral effects in a cohort (n=200) with occupational and community exposures to pesticide drift containing organophosphates from orchards and cotton fields in the Hula Valley. We aim (1) to re-examine neurobehavioral outcomes in members of the original cohort and (2) to examine cognitive effects in children with residential exposures. In adults, we will carry out assays of alkyl phosphates, PON1 (paraoxonase-1), NTE (Neuropathy Target Esterase), neurobehavioral tests of cognitive and performance skills, nerve conduction measurements and mood status. We will carry out Psycho-Didactic tests in children. The findings will advance knowledge on delayed term health effects of lengthy everyday exposure to OP pesticides and guide regulatory policy.
- Conditions
- Peripheral Neuropathy
- Keywords
- OP, Pesticides, Long-Term Low Level Exposure, Occupational Health, Neurobehavioral Effects
- Medical subject headings
- Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Agricultural Workers | |
| 2 | Non - Agricultural Workers | |
| 3 | Kibbitz Residents working else where |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies 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
- Cohort
- Time perspective
- Cross-sectional
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671866
- Sponsor's protocol ID
- y.finkelstein.ctil.
- Status last verified
- Apr 2008
- First submitted
- 30 Apr 2008
- Last updated
- 5 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurotoxic Health Hazards of Long-Term Low-Level Exposure to Organophosphate (OP) Compounds in in Hula Valley
- ClinicalTrials.gov ID
- NCT00671866
- Acronym / sponsor ID
- y.finkelstein.ctil.
- Conditions
- Peripheral Neuropathy
- Keywords
- OP, Pesticides, Long-Term Low Level Exposure, Occupational Health, Neurobehavioral Effects
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- First posted
- 5 May 2008 (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.
During 1987-1991, WHO supported studies of exposures and short term neurobehavioral effects in a cohort (n=200) with occupational and community exposures to pesticide drift containing organophosphates from orchards and cotton fields in the Hula Valley. We aim (1) to re-examine neurobehavioral outcomes in members of the original cohort and (2) to examine cognitive effects in children with residential exposures. In adults, we will carry out assays of alkyl phosphates, PON1 (paraoxonase-1), NTE (Neuropathy Target Esterase), neurobehavioral tests of cognitive and performance skills, nerve conduction measurements and mood status. We will carry out Psycho-Didactic tests in children. The findings will advance knowledge on delayed term health effects of lengthy everyday exposure to OP pesticides and guide regulatory policy.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Agricultural Workers |
| 2 | – | –Non - Agricultural Workers |
| 3 | – | –Kibbitz Residents working else where |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Residents of Kibbutzim
Key inclusion criteria (1 listed)
- Participants of the former study twenty years ago
Key exclusion criteria (0 listed)
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2008.
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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.
Neurology and Toxicology Unit and Service, Shaare Zedek Med Ctr
Jerusalem, Israel
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 Peripheral Neuropathy, run by Shaare Zedek Medical Center at 1 site in Israel.
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 0 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: status not confirmed, as of the sponsor's last update on 5 May 2008. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 5 May 2008.