Overview

This trial has been completed.

Condition pesticide poisoning
Treatment ultraviolet light-resistant plastic in-ground pesticide storage container
Sponsor University of Edinburgh
Collaborator University of Bristol
Start date December 2010
End date May 2013
Trial size 223000 participants
Trial identifier NCT01146496, Safe Storage Protocol Sep09

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
Ultraviolet light resistant plastic in-ground pesticide storage container
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
(No Intervention)

Primary Outcomes

Measure
Incidence of pesticide self-poisoning
time frame: For three years after intervention

Secondary Outcomes

Measure
Incidence of all self-poisoning
time frame: For three years post-intervention
Incidence of all self-harm
time frame: For three years after intervention
Incidence of fatal self-harm
time frame: For three years post intervention
Incidence of pesticide poisoning
time frame: For three years post intervention
Incidence of unintentional paediatric pesticide poisoning
time frame: For three years post intervention

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Any village in the study area that gives consent to the study Exclusion Criteria:

Additional Information

Official title A Community Trial to Determine Whether 'Safe Storage' Reduces Pesticide Self-poisoning in Rural Asia
Principal investigator Michael Eddleston
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Edinburgh.