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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01146496
Recruitment Status : Completed
First Posted : June 17, 2010
Results First Posted : July 5, 2019
Last Update Posted : July 18, 2019
Sponsor:
Collaborators:
University of Bristol
University of Oxford
University of Peradeniya
University of Kelaniya
University of Copenhagen
Information provided by (Responsible Party):
University of Edinburgh

Brief 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.

Condition or disease Intervention/treatment Phase
Pesticide Poisoning Device: Ultraviolet light-resistant plastic in-ground pesticide storage container Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 223861 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pesticides Poisoning

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Incidence of All Self-poisoning [ Time Frame: For three years post-intervention ]
    Cases of self-poisoning identified

  2. Incidence of All Self-harm [ Time Frame: For three years after intervention ]
  3. Incidence of Fatal Self-harm [ Time Frame: For three years post intervention ]
  4. Incidence of Pesticide Poisoning [ Time Frame: For three years post intervention ]
  5. Incidence of Unintentional Paediatric Pesticide Poisoning [ Time Frame: For three years post intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

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


Locations
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Sri Lanka
Mahaweli H area
Anuradhapura, North Central Province, Sri Lanka
Sponsors and Collaborators
University of Edinburgh
University of Bristol
University of Oxford
University of Peradeniya
University of Kelaniya
University of Copenhagen
Investigators
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Principal Investigator: Michael Eddleston University of Edinburgh
Study Director: Flemming Konradsen University of Copenhagen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01146496    
Other Study ID Numbers: Safe Storage Protocol Sep09
First Posted: June 17, 2010    Key Record Dates
Results First Posted: July 5, 2019
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Edinburgh:
Pesticide poisoning
Suicide
Unintentional poisoning
Prevention
Cluster randomised controlled trial
Additional relevant MeSH terms:
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Poisoning
Chemically-Induced Disorders