Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Edinburgh.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
University of Bristol
University of Oxford
University of Peradeniya
University of Kelaniya
University of Copenhagen
Information provided by:
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01146496
First received: June 16, 2010
Last updated: June 30, 2010
Last verified: June 2010
  Purpose

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 Intervention
Pesticide Poisoning
Device: Ultraviolet light-resistant plastic in-ground pesticide storage container

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Community Trial to Determine Whether 'Safe Storage' Reduces Pesticide Self-poisoning in Rural Asia

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Incidence of pesticide self-poisoning [ Time Frame: For three years after intervention ] [ Designated as safety issue: No ]
    Cases identified by survey of local and referral hospitals and by regular interview of primary informants in each village


Secondary Outcome Measures:
  • Incidence of all self-poisoning [ Time Frame: For three years post-intervention ] [ Designated as safety issue: No ]
  • Incidence of all self-harm [ Time Frame: For three years after intervention ] [ Designated as safety issue: No ]
  • Incidence of fatal self-harm [ Time Frame: For three years post intervention ] [ Designated as safety issue: No ]
  • Incidence of pesticide poisoning [ Time Frame: For three years post intervention ] [ Designated as safety issue: No ]
  • Incidence of unintentional paediatric pesticide poisoning [ Time Frame: For three years post intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 190000
Study Start Date: December 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01146496

Contacts
Contact: Michael Eddleston, MA PhD MRCP +44-131-242-9214 m.eddleston@ed.ac.uk
Contact: Flemming Konradsen

Locations
Sri Lanka
Mahaweli H area Not yet recruiting
Anuradhapura District, 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
Principal Investigator: Michael Eddleston University of Edinburgh
Study Director: Flemming Konradsen University of Copenhagen
  More Information

No publications provided by University of Edinburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Eddleston, University of Edinburgh
ClinicalTrials.gov Identifier: NCT01146496     History of Changes
Other Study ID Numbers: Safe Storage Protocol Sep09
Study First Received: June 16, 2010
Last Updated: June 30, 2010
Health Authority: Sri Lanka: Ministry of Healthcare & Nutrition

Keywords provided by University of Edinburgh:
Pesticide poisoning
Suicide
Unintentional poisoning
Prevention
Cluster randomised controlled trial

Additional relevant MeSH terms:
Poisoning
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on November 25, 2014