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

Not Applicable

Completed

• Conditions: Organophosphate Poisoning
• Interventions: Other: Organophosphate; Other: Placebo

• Registration Number: NCT02838303
• Lead Sponsor: Bispebjerg Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Study First Submitted: 2016-07-14
• Study First Submitted QC: 2016-07-17
• Study First Posted: 2016-07-20
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-27
• Last Update Posted: 2023-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 42

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A	Organophosphate	Initial spray session: organophosphate. Crossover spray session: placebo
Group A	Placebo	Initial spray session: organophosphate. Crossover spray session: placebo
Group B	Organophosphate	Initial spray session: placebo. Crossover spray session: organophosphate
Group B	Placebo	Initial spray session: placebo. Crossover spray session: organophosphate

Primary Outcome Measures

Name	Time	Method
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.
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).