A Community Trial to Determine Whether 'Safe Storage' Reduces Pesticide Self-poisoning in Rural Asia

Pesticide Poisoning Clinical Trial

Official title:

A Community Trial to Determine Whether 'Safe Storage' Reduces Pesticide Self-poisoning in Rural Asia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01146496
• Other study ID #: Safe Storage Protocol Sep09
• Status: Completed
• Phase: N/A
• Start date: December 2010
• Est. completion date: June 2016

Study information

• Verified date: July 2019
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A major global public health priority is to identify effective methods for preventing deaths from pesticide self-poisoning. The aim of this work is to determine whether the provision of lockable storage containers to poor households in rural Asia can reduce the incidence of intentional pesticide self-poisoning. Secondary questions include the effect of these containers on unintentional pesticide poisoning in children and overall self-harm.

Description:

We will set up a large community-based, cluster randomised controlled trial of 162 villages (mean adult population 900) in rural Sri Lanka to determine the effectiveness and cost of the provision of safe storage containers to prevent pesticide poisoning.

The study will be based in Anuradhapura District where we have carried out public health studies of pesticide poisoning since 2002. 81 intervention and 81 control villages will be recruited. Randomisation will be clustered, with villages rather than households randomised. A census will be performed at baseline and after 3 years to establish the population demographics and number of person-years exposed.

The primary outcome will be the incidence of pesticide self-poisoning; secondary outcomes will be the incidence of all self-poisoning, all self-harm, fatal self-harm, pesticide poisoning and unintentional paediatric pesticide poisoning. We will use Poisson regression models, taking account of clustering and stratification, for the analysis.

The study will provide definitive evidence concerning the cost-effectiveness of this approach that will determine whether it should be promoted across Asia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223861
• Est. completion date: June 2016
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Any village in the study area that gives consent to the study

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Pesticide Poisoning
• Poisoning

Intervention

Device:
• Ultraviolet light-resistant plastic in-ground pesticide storage container
In-ground pesticide storage container to be supplied to every household that uses pesticides in intervention villages

Locations

Country	Name	City	State
Sri Lanka	Mahaweli H area	Anuradhapura	North Central Province

Sponsors (6)

Lead Sponsor	Collaborator
University of Edinburgh	University of Bristol, University of Copenhagen, University of Kelaniya, University of Oxford, University of Peradeniya

Country where clinical trial is conducted

Sri Lanka, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Pesticide Self-poisoning	Cases identified by survey of local and referral hospitals and by regular interview of primary informants in each village	For three years after intervention
Secondary	Incidence of All Self-poisoning	Cases of self-poisoning identified	For three years post-intervention
Secondary	Incidence of All Self-harm		For three years after intervention
Secondary	Incidence of Fatal Self-harm		For three years post intervention
Secondary	Incidence of Pesticide Poisoning		For three years post intervention
Secondary	Incidence of Unintentional Paediatric Pesticide Poisoning		For three years post intervention