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

Sponsor
Bispebjerg Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02838303
Collaborator
Augustinus Fonden (Other)
42
Enrollment
2
Arms
2
Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Organophosphate
  • Other: Placebo
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Diagnostic
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 Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Nov 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Other: Group A

Initial spray session: organophosphate. Crossover spray session: placebo

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

Other: Placebo
Multineem, WHO Class U: Unlikely to present acute hazard in normal use
Other Names:
  • Biopesticide

    		•
    Other: Group B

    Initial spray session: placebo. Crossover spray session: organophosphate

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

    Other: Placebo
    Multineem, WHO Class U: Unlikely to present acute hazard in normal use
    Other Names:
  • Biopesticide

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in self-reported acute organophosphate poisoning symptoms from baseline to follow up [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.

    2. Change in Plasma Cholinesterase (PchE) activity from baseline to follow up [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Bispebjerg Hospital
    • Augustinus Fonden

    Investigators

    • Principal Investigator: Dea H. Kofod, MB, Department of Occupational and Environmental Medicine, Bispebjerg Frederiksberg Hospital, University of Copenhagen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dea Haagensen Kofod, MB, Bispebjerg Hospital
    ClinicalTrials.gov Identifier:
    NCT02838303
    Other Study ID Numbers:
    • 12205-01-57-02
    First Posted:
    Jul 20, 2016
    Last Update Posted:
    Jul 20, 2016
    Last Verified:
    Jul 1, 2016
    Additional relevant MeSH terms:
    Poisoning
    Organophosphate Poisoning

    Study Results

    No Results Posted as of Jul 20, 2016