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Trial record 1 of 1 for:    NCT02838303
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The Use of Self-reported Symptoms as a Proxy for Acute Organophosphate Poisoning Among Nepali Farmers

This study has been completed.
Sponsor:
Collaborator:
Augustinus Fonden
Information provided by (Responsible Party):
Dea Haagensen Kofod, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT02838303
First received: July 14, 2016
Last updated: July 17, 2016
Last verified: July 2016
  Purpose
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 Intervention
Organophosphate Poisoning Other: Organophosphate Other: Placebo

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Dea Haagensen Kofod, Bispebjerg Hospital:

Primary Outcome Measures:
  • 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).


Enrollment: 42
Study Start Date: September 2014
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Biopesticide
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 Name: Biopesticide

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02838303

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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dea Haagensen Kofod, MB, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT02838303     History of Changes
Other Study ID Numbers: 12205-01-57-02
Study First Received: July 14, 2016
Last Updated: July 17, 2016

Additional relevant MeSH terms:
Poisoning
Organophosphate Poisoning
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on September 20, 2017