Farming, Personal Protective Equipment, Nepal

NCT02137317 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2015-02-23

No results posted yet for this study

Summary

According to the World Health Organization pesticide poisoning is a major health problem due to the millions of cases annually occurring worldwide. Farmers have a particularly high risk of pesticide poisoning because of their work involving pesticide use to protect crops. The majority of pesticide poisonings occur in developing countries. On a short term it is not realistic to reduce farmers' use of pesticides significantly because it would require that secure and cost-effective alternatives are introduced. This is a lengthy process, which should undoubtedly be supported. However, it becomes as important to make sure that farmers can protect themselves from pesticide exposure meanwhile. Use of personal protective equipment can minimize pesticide exposure on farmers' bodies and consequently reduce their risk of pesticide poisoning. However, the sparse research identified through a systematic literature review shows that we are not in a position to give recommendations on what personal protective equipment farmers should protect themselves with against pesticide exposure suitable to their specific conditions. The purpose of the present study is to examine factors that influence farmers' use of personal protective equipment during their work with organophosphates and, based on this examine the ability of locally adapted personal protective equipment to reduce their organophosphate exposure. The hypothesis is that farmers working in locally adapted personal protective equipment have less acute organophosphate poisoning symptoms, a higher plasma cholinesterase level and find it to be a more feasible solution than farmers working in their daily practice wearing. Examining how locally adapted personal protective equipment (onwards referred to as the LAPPE solution) performs in practice implies testing it in an intervention study. A randomized crossover experiment design is chosen partly because fewer farmers have to be recruited since each farmer will act as his own control and partly because the between farmer variation is strongly reduced. The performance of the LAPPE solution will be tested in one experiment and compared to the performance of the same farmers' daily practice wearing (onwards referred to as the DP solution) in another experiment. The LAPPE solution is expected to have a superior performance. The participation sequence (LAPPE/DP or DP/LAPPE) will be randomized. The study will be conducted among farmers in Chitwan, Nepal.

Conditions

  • Organophosphate Poisoning

Interventions

DEVICE

LAPPE (locally adapted personal protective equipment)

* Hand: Nitrile gloves flexible enough to grip pesticide container firmly and in a length appropriate for mixing and spraying such as wrist length. They should not contain lining inside. In case, nothing is available disposable plastic bags can provide sufficient protection. In both cases wearing a cotton glove underneath. * Upper and lower body: As thick or as heavy cotton blouse and trousers as can be worn and plastic sheets cut as a long poncho. * Feet: Unlined rubber boots or shoes at least calf height with thick cotton socks underneath with possibility for trousers to be worn outside rubber boots or shoes.

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER
  • Odense University Hospital

    collaborator OTHER
  • Dialogos

    collaborator UNKNOWN
  • Nepal Development Society

    collaborator UNKNOWN
  • Nepal Public Health Foundation

    collaborator UNKNOWN
  • Nepal Red Cross Society

    collaborator UNKNOWN
  • Dansk Selskab for Arbejds- og Miljømedicin

    collaborator UNKNOWN
  • The Augustinus Foundation, Denmark.

    collaborator OTHER
  • Else og Mogens Wedell Wedellsborgs Foundation

    collaborator UNKNOWN
  • Syngenta

    collaborator UNKNOWN
  • BASF

    collaborator INDUSTRY
  • Bispebjerg Hospital

    lead OTHER

Principal Investigators

  • Anshu Varma · Bispebjerg Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Nepal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02137317 on ClinicalTrials.gov