A Community Trial to Determine Whether 'Safe Storage' Reduces Pesticide Self-poisoning in Rural Asia
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|ClinicalTrials.gov Identifier: NCT01146496|
Recruitment Status : Completed
First Posted : June 17, 2010
Last Update Posted : November 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pesticide Poisoning||Device: Ultraviolet light-resistant plastic in-ground pesticide storage container||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||223000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Community Trial to Determine Whether 'Safe Storage' Reduces Pesticide Self-poisoning in Rural Asia|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||June 2016|
Active Comparator: Storage container
Ultraviolet light resistant plastic in-ground pesticide storage container
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
|No Intervention: Control|
- Incidence of pesticide self-poisoning [ Time Frame: For three years after intervention ]Cases identified by survey of local and referral hospitals and by regular interview of primary informants in each village
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01146496
|Mahaweli H area|
|Anuradhapura District, North Central Province, Sri Lanka|
|Principal Investigator:||Michael Eddleston||University of Edinburgh|
|Study Director:||Flemming Konradsen||University of Copenhagen|