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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: Bispebjerg Hospital

Current Primary Outcome:

• Change in self-reported acute organophosphate poisoning symptoms from baseline to follow up [ Time Frame: 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 [ Time Frame: 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).

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Bispebjerg Hospital

Dates:
Date Received: July 14, 2016
Date Started: September 2014
Date Completion:
Last Updated: July 17, 2016
Last Verified: July 2016