The Use of Self-reported Symptoms as a Proxy for Acute Organophosphate Poisoning Among Nepali Farmers

NCT ID: NCT02838303

Last Updated: 2023-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Organophosphate Poisoning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A

Initial spray session: organophosphate. Crossover spray session: placebo

Group Type OTHER

Organophosphate

Intervention Type OTHER

Chlorpyrifos 50% plus cypermethrin 5%, WHO Class II: Moderately hazardous

Placebo

Intervention Type OTHER

Multineem, WHO Class U: Unlikely to present acute hazard in normal use

Group B

Initial spray session: placebo. Crossover spray session: organophosphate

Group Type OTHER

Organophosphate

Intervention Type OTHER

Chlorpyrifos 50% plus cypermethrin 5%, WHO Class II: Moderately hazardous

Placebo

Intervention Type OTHER

Multineem, WHO Class U: Unlikely to present acute hazard in normal use

Interventions

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Organophosphate

Chlorpyrifos 50% plus cypermethrin 5%, WHO Class II: Moderately hazardous

Intervention Type OTHER

Placebo

Multineem, WHO Class U: Unlikely to present acute hazard in normal use

Intervention Type OTHER

Other Intervention Names

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Biopesticide

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Augustinus Fonden

OTHER

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dea Haagensen Kofod

MB

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dea H. Kofod, MB

Role: PRINCIPAL_INVESTIGATOR

Department of Occupational and Environmental Medicine, Bispebjerg Frederiksberg Hospital, University of Copenhagen

References

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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.

Reference Type DERIVED
PMID: 27964728 (View on PubMed)

Other Identifiers

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12205-01-57-02

Identifier Type: -

Identifier Source: org_study_id

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