Organophosphate PoisoningNCT02838303
The Use of Self-reported Symptoms as a Proxy for Acute Organophosphate Poisoning Among Nepali Farmers
A study testing Organophosphate in people with Organophosphate Poisoning, run by Bispebjerg Hospital.
Trial summary
The purpose of this study is to evaluate self-reported symptoms as a proxy for acute organophosphate poisoning by examining self-reported acute organophosphate poisoning symptoms and PchE activity in response to occupational acute organophosphate exposure among farmers in Nepal. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Organophosphate Poisoning
- What is being tested?
- Organophosphate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Nov 2014
- Phase
- Interventional
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male
- minimum age 18 years
- hand pressured backpack sprayer usage
- used to spray with moderately to extremely hazardous pesticides according to the World Health Organization's (WHO) Pesticide Hazard Classification
Who cannot join
- usual personal protective equipment use (respirator/mask with particulate filter, face shield, googles, gloves, boots, plastic poncho)
- unwilling to stay pesticide-free seven days prior to each of the two spray sessions
- medical conditions interfering with PchE activity (liver disease, acute infection, chronic malnutrition, heart attack, cancer, obstructive jaundice, inflammation caused by various diseases, or use of pyridostigmine drugs)
About this study
Official title: The Use of Self-reported Symptoms as a Proxy for Acute Organophosphate Poisoning Among Nepali Farmers: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study
The purpose of this study is to evaluate self-reported symptoms as a proxy for acute organophosphate poisoning by examining self-reported acute organophosphate poisoning symptoms and PchE activity in response to occupational acute organophosphate exposure among farmers in Nepal.
- Conditions
- Organophosphate Poisoning
- Being tested
- Organophosphate, Placebo
- Medical subject headings
- Organophosphate Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrganophosphateOther
Chlorpyrifos 50% plus cypermethrin 5%, WHO Class II: Moderately hazardous
PlaceboOther
Also called Biopesticide
Multineem, WHO Class U: Unlikely to present acute hazard in normal use
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | Initial spray session: organophosphate. Crossover spray session: placebo Receives: Other: Organophosphate; Other: Placebo |
| Group B | Other | Initial spray session: placebo. Crossover spray session: organophosphate Receives: Other: Organophosphate; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported acute organophosphate poisoning symptoms from baseline to follow up
Obtained using a structured questionnaire interview. The definition of symptoms was based on WHO's standardized list of clinical presentations of acute organophosphate poisoning.
Measured: Obtained just before (baseline) and 30 minutes after (baseline) each spray session
Change in Plasma Cholinesterase (PchE) activity from baseline to follow up
PchE activity was measured with a blood test using a Test-mate Che Cholinesterase System (Model 400) with a PchE Plasma Cholinesterase Assay Kit (Model 470).
Measured: Obtained just before (baseline) and 30 minutes after (baseline) each spray session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startSep 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Organophosphate PoisoningStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Augustinus Fonden
- Responsible party
- Principal investigator, Dea Haagensen Kofod, Bispebjerg Hospital
- Investigators
- Dea H. Kofod, MB, Principal investigator, Department of Occupational and Environmental Medicine, Bispebjerg Frederiksberg Hospital, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838303
- Sponsor's protocol ID
- 12205-01-57-02
- Status last verified
- Jul 2023
- First submitted
- 14 Jul 2016
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Kofod DH, Jors E, Varma A, Bhatta S, Thomsen JF. The use of self-reported symptoms as a proxy for acute organophosphate poisoning after exposure to chlorpyrifos 50% plus cypermethrin 5% among Nepali farmers: a randomized, double-blind, placebo-controlled, crossover study. Environ Health. 2016 Dec 13;15(1):122. doi: 10.1186/s12940-016-0205-1.
PubMed 27964728
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Self-reported Symptoms as a Proxy for Acute Organophosphate Poisoning Among Nepali Farmers: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study
- ClinicalTrials.gov ID
- NCT02838303
- Acronym / sponsor ID
- 12205-01-57-02
- Conditions
- Organophosphate Poisoning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Augustinus Fonden
- Study start
- Sep 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 20 Jul 2016 (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.
The purpose of this study is to evaluate self-reported symptoms as a proxy for acute organophosphate poisoning by examining self-reported acute organophosphate poisoning symptoms and PchE activity in response to occupational acute organophosphate exposure among farmers in Nepal.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Other: Organophosphate, Other: PlaceboInitial spray session: organophosphate. Crossover spray session: placebo |
| Group B | Other | Other: Organophosphate, Other: PlaceboInitial spray session: placebo. Crossover spray session: organophosphate |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male
- minimum age 18 years
- hand pressured backpack sprayer usage
- used to spray with moderately to extremely hazardous pesticides according to the World Health Organization's (WHO) Pesticide Hazard Classification
Key exclusion criteria (3 listed)
- usual personal protective equipment use (respirator/mask with particulate filter, face shield, googles, gloves, boots, plastic poncho)
- unwilling to stay pesticide-free seven days prior to each of the two spray sessions
- medical conditions interfering with PchE activity (liver disease, acute infection, chronic malnutrition, heart attack, cancer, obstructive jaundice, inflammation caused by various diseases, or use of pyridostigmine drugs)
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 |
|---|---|---|
| OrganophosphateChlorpyrifos 50% plus cypermethrin 5%, WHO Class II: Moderately hazardous | Other | Group A, Group B |
| PlaceboAlso: BiopesticideMultineem, WHO Class U: Unlikely to present acute hazard in normal use | Other | Group A, Group B |
Primary outcome
Change in self-reported acute organophosphate poisoning symptoms from baseline to follow up
Time frame: Obtained just before (baseline) and 30 minutes after (baseline) each spray session
Obtained using a structured questionnaire interview. The definition of symptoms was based on WHO's standardized list of clinical presentations of acute organophosphate poisoning.
Change in Plasma Cholinesterase (PchE) activity from baseline to follow up
Time frame: Obtained just before (baseline) and 30 minutes after (baseline) each spray session
PchE activity was measured with a blood test using a Test-mate Che Cholinesterase System (Model 400) with a PchE Plasma Cholinesterase Assay Kit (Model 470).
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 28 Jul 2023.
- Derived from this study: PubMed 27964728Kofod DH, Jors E, Varma A, Bhatta S, Thomsen JF. The use of self-reported symptoms as a proxy for acute organophosphate poisoning after exposure to chlorpyrifos 50% plus cypermethrin 5% among Nepali farmers: a randomized, double-blind, placebo-controlled, crossover study. Environ Health. 2016 Dec 13;15(1):122. doi: 10.1186/s12940-016-0205-1.
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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.
Dea H. Kofod, MB principal investigator
Department of Occupational and Environmental Medicine, Bispebjerg Frederiksberg Hospital, University of Copenhagen
Questions about this trial
What is this clinical trial studying?
A study testing Organophosphate in people with Organophosphate Poisoning, run by Bispebjerg Hospital.
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 4 inclusion and 3 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 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in self-reported acute organophosphate poisoning symptoms from baseline to follow up (time frame: Obtained just before (baseline) and 30 minutes after (baseline) each spray session). The study lists 2 primary outcomes in all. 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 NCT02838303, which also lists 1 linked publication.
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 28 Jul 2023.