Farming, Personal Protective Equipment, Nepal

• Register: ClinicalTrials.gov
• Last refreshed on: 2 March 2015
• Main ID: NCT02137317
• Date of registration: 07/05/2014
• Prospective Registration: Yes
• Primary sponsor: Bispebjerg Hospital
• Public title: Farming, Personal Protective Equipment, Nepal
• Scientific title: Prevention of Farmers' Exposure to Pesticides With Relevant Personal Protective Equipment in Chitwan District of Nepal
• Date of first enrolment: August 2014
• Target sample size: 45
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02137317
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: N/A

Countries of recruitment

Nepal

Contacts

• Name: Anshu Varma
• Affiliation: Bispebjerg Hospital

Key inclusion & exclusion criteria

Inclusion

- 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).

Exclusion

- 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).



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Organophosphate Poisoning

Intervention(s)

Device: LAPPE (locally adapted personal protective equipment)

Primary Outcome(s)

Plasma Cholinesterase [Time Frame: Farmers will be followed over 15 days (cholinesterase measured four times)]

Secondary Outcome(s)

Acute Organophosphate Poisoning Symptoms [Time Frame: Farmers will be followed for 15 days (symptoms measured four times)]

Secondary ID(s)

FAPPEN

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Else og Mogens Wedell Wedellsborgs Foundation

Dansk Selskab for Arbejds- og Miljømedicin

Odense University Hospital

The Augustinus Foundation, Denmark.

BASF

Nepal Public Health Foundation

Dialogos

Nepal Red Cross Society

Syngenta

Nepal Development Society

University of Copenhagen