Farming, Personal Protective Equipment, Nepal

NCT02137317 | Completed

• 1 other identifier: FAPPEN
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pesticides; Personal protective equipment; Developing countries; Tropical Climate

Outcome Measures

Primary Outcomes (1)

• Plasma Cholinesterase

  Plasma cholinesterase is a substance necessary for the proper functioning of the human nervous system. The inhibition of this type of cholinesterase is considered as a useful indicator of exposure to organophosphates when measured before and after likely exposure. Plasma cholinesterase will be measured with a Test-mate Cholinesterase System (Model 400) requiring 10 microliters (µL) for a blood test.

  Farmers will be followed over 15 days (cholinesterase measured four times)

Secondary Outcomes (1)

• Acute Organophosphate Poisoning Symptoms

  Farmers will be followed for 15 days (symptoms measured four times)

Other Outcomes (1)

• Feasibility

  Farmers will be followed over 15 days (measured two times)

Study Arms (2)

LAPPE/DP

EXPERIMENTAL

In the LAPPE experiment the farmer will work as usual (mixing/loading/application/cleaning). wearing the LAPPE solution and carrying a new hand pressured backpack sprayer with a standardized nozzle. Conditions such as dosage, work practices and weather conditions will remain uncontrolled but be observed. After one week this process will be repeated wearing the DP solution.

Device: LAPPE (locally adapted personal protective equipment)

DP/LAPPE

ACTIVE COMPARATOR

In the DP experiment the farmer will work as usual (mixing/loading/application/cleaning) wearing the DP solution and carrying his usual backpack sprayer with his usual nozzle. Conditions such as dosage, work practices and weather conditions will remain uncontrolled but be observed. After one week this process will be repeated wearing the LAPPE solution.

Device: LAPPE (locally adapted personal protective equipment)

Interventions

LAPPE (locally adapted personal protective equipment) DEVICE

* 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.

DP/LAPPE; LAPPE/DP

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male (females usually wear national dresses considered to provide adequate protection (43).
• Age min. 18 years (implies being a legal worker).
• Grows crops in knee and abdomen height in given data collection period.
• Willing to spend 1.5-3 hours working with organophosphates under normal working conditions.
• Involved in farming minimum two years (implies being active).
• Usually sprays at least once in two weeks with organophosphates on average (implies being active).
• Uses a hand pressured backpack sprayer placed at home (necessary to complete non-intervention).
• Works with crops in 5-10 katha land (sufficient to apply organophosphates for given time).
• Has a mobile/landline number (necessary for easy contact).

You may not qualify if:

• Has a helper during work with organophosphates (organophosphate exposure reduced).
• Is unwilling to stay organophosphate free one week prior to each of two experiment days (necessary for comparable measurements).
• Has any of the following conditions: liver disease/damage, alcoholic/viral hepatitis, acute infection, chronic malnutrition, heart attack, metastasis, obstructive jaundice, inflammation, uses pyridostigmine drugs (decreases or increases plasma cholinesterase) (44-46).

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• University of Copenhagen: collaborator
• Odense University Hospital: collaborator
• Dialogos: collaborator
• Nepal Development Society: collaborator
• Nepal Public Health Foundation: collaborator
• Nepal Red Cross Society: collaborator
• Dansk Selskab for Arbejds- og Miljømedicin: collaborator
• The Augustinus Foundation, Denmark.: collaborator
• Else og Mogens Wedell Wedellsborgs Foundation: collaborator
• Syngenta: collaborator
• BASF: collaborator

Study Sites (1)

FAPPEN - Field

Bharatpur, Chitwan, Nepal

Location

Related Publications (51)

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MeSH Terms

Conditions

Organophosphate Poisoning

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders

Study Officials

• Anshu Varma

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cand.scient.san.publ

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 13, 2014
• Study Start: August 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: February 23, 2015

Record last verified: 2015-02

Locations

NE (1)