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

Primary Purpose

Organophosphate Poisoning

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Organophosphate
Placebo
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Organophosphate Poisoning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Group A

    Group B

    Arm Description

    Initial spray session: organophosphate. Crossover spray session: placebo

    Initial spray session: placebo. Crossover spray session: organophosphate

    Outcomes

    Primary Outcome Measures

    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.
    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).

    Secondary Outcome Measures

    Full Information

    First Posted
    July 14, 2016
    Last Updated
    July 27, 2023
    Sponsor
    Bispebjerg Hospital
    Collaborators
    Augustinus Fonden
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02838303
    Brief Title
    The Use of Self-reported Symptoms as a Proxy for Acute Organophosphate Poisoning Among Nepali Farmers
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    November 2014 (Actual)
    Study Completion Date
    November 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bispebjerg Hospital
    Collaborators
    Augustinus Fonden

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Organophosphate Poisoning

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    42 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Other
    Arm Description
    Initial spray session: organophosphate. Crossover spray session: placebo
    Arm Title
    Group B
    Arm Type
    Other
    Arm Description
    Initial spray session: placebo. Crossover spray session: organophosphate
    Intervention Type
    Other
    Intervention Name(s)
    Organophosphate
    Intervention Description
    Chlorpyrifos 50% plus cypermethrin 5%, WHO Class II: Moderately hazardous
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Biopesticide
    Intervention Description
    Multineem, WHO Class U: Unlikely to present acute hazard in normal use
    Primary Outcome Measure Information:
    Title
    Change in self-reported acute organophosphate poisoning symptoms from baseline to follow up
    Description
    Obtained using a structured questionnaire interview. The definition of symptoms was based on WHO's standardized list of clinical presentations of acute organophosphate poisoning.
    Time Frame
    Obtained just before (baseline) and 30 minutes after (baseline) each spray session
    Title
    Change in Plasma Cholinesterase (PchE) activity from baseline to follow up
    Description
    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).
    Time Frame
    Obtained just before (baseline) and 30 minutes after (baseline) each spray session

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dea H. Kofod, MB
    Organizational Affiliation
    Department of Occupational and Environmental Medicine, Bispebjerg Frederiksberg Hospital, University of Copenhagen
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27964728
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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