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

Organophosphate Poisoning Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02838303
• Other study ID #: 12205-01-57-02
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: November 2014

Study information

• Verified date: July 2023
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Organophosphate Poisoning
• Poisoning

Intervention

Other:
• Organophosphate
Chlorpyrifos 50% plus cypermethrin 5%, WHO Class II: Moderately hazardous
• Placebo
Multineem, WHO Class U: Unlikely to present acute hazard in normal use

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Augustinus Fonden

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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