NCT02838303

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
Last Updated

July 28, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

July 14, 2016

Last Update Submit

July 27, 2023

Conditions

Organophosphate Poisoning

Outcome Measures

Primary Outcomes (2)

  • 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.

    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).

    Obtained just before (baseline) and 30 minutes after (baseline) each spray session

Study Arms (2)

Group A

OTHER

Initial spray session: organophosphate. Crossover spray session: placebo

Other: OrganophosphateOther: Placebo

Group B

OTHER

Initial spray session: placebo. Crossover spray session: organophosphate

Other: OrganophosphateOther: Placebo

Interventions

OrganophosphateOTHER

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

Group AGroup B
PlaceboOTHER

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

Also known as: Biopesticide
Group AGroup B

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 27964728DERIVED

MeSH Terms

Conditions

Organophosphate Poisoning

Interventions

OrganophosphatesBiological Control Agents

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Organophosphorus CompoundsOrganic ChemicalsBiological ProductsComplex Mixtures

Study Officials

  • Dea H. Kofod, MB

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MB

Study Record Dates

First Submitted

July 14, 2016

First Posted

July 20, 2016

Study Start

September 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

July 28, 2023

Record last verified: 2023-07