NCT01146496

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223,861

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

July 5, 2019

Completed
Last Updated

July 18, 2019

Status Verified

July 1, 2019

Enrollment Period

2.4 years

First QC Date

June 16, 2010

Results QC Date

April 16, 2019

Last Update Submit

July 4, 2019

Conditions

Keywords

Pesticide poisoningSuicideUnintentional poisoningPreventionCluster randomised controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Incidence of All Self-poisoning

    For three years post-intervention

  • Incidence of All Self-harm

    For three years after intervention

  • Incidence of Fatal Self-harm

    For three years post intervention

  • Incidence of Pesticide Poisoning

    For three years post intervention

  • Incidence of Unintentional Paediatric Pesticide Poisoning

    For three years post intervention

Study Arms (2)

Storage container

ACTIVE COMPARATOR

Ultraviolet light resistant plastic in-ground pesticide storage container

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

Control

NO INTERVENTION

Interventions

In-ground pesticide storage container to be supplied to every household that uses pesticides in intervention villages

Storage container

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahaweli H area

Anuradhapura, North Central Province, Sri Lanka

Location

Related Publications (4)

  • Pearson M, Metcalfe C, Jayamanne S, Gunnell D, Weerasinghe M, Pieris R, Priyadarshana C, Knipe DW, Hawton K, Dawson AH, Bandara P, deSilva D, Gawarammana I, Eddleston M, Konradsen F. Effectiveness of household lockable pesticide storage to reduce pesticide self-poisoning in rural Asia: a community-based, cluster-randomised controlled trial. Lancet. 2017 Oct 21;390(10105):1863-1872. doi: 10.1016/S0140-6736(17)31961-X. Epub 2017 Aug 11.

  • Knipe DW, Gunnell D, Pieris R, Priyadarshana C, Weerasinghe M, Pearson M, Jayamanne S, Dawson AH, Mohamed F, Gawarammana I, Hawton K, Konradsen F, Eddleston M, Metcalfe C. Is socioeconomic position associated with risk of attempted suicide in rural Sri Lanka? A cross-sectional study of 165 000 individuals. BMJ Open. 2017 Mar 22;7(3):e014006. doi: 10.1136/bmjopen-2016-014006.

  • Madsen LB, Eddleston M, Hansen KS, Pearson M, Agampodi S, Jayamanne S, Konradsen F. Cost-effectiveness analyses of self-harm strategies aimed at reducing the mortality of pesticide self-poisonings in Sri Lanka: a study protocol. BMJ Open. 2015 Feb 27;5(2):e007333. doi: 10.1136/bmjopen-2014-007333.

  • Pearson M, Konradsen F, Gunnell D, Dawson AH, Pieris R, Weerasinghe M, Knipe DW, Jayamanne S, Metcalfe C, Hawton K, Wickramasinghe AR, Atapattu W, Bandara P, de Silva D, Ranasinghe A, Mohamed F, Buckley NA, Gawarammana I, Eddleston M. A community-based cluster randomised trial of safe storage to reduce pesticide self-poisoning in rural Sri Lanka: study protocol. BMC Public Health. 2011 Nov 21;11:879. doi: 10.1186/1471-2458-11-879.

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Results Point of Contact

Title
Michael Eddleston
Organization
University of Edinburgh

Study Officials

  • Michael Eddleston

    University of Edinburgh

    PRINCIPAL INVESTIGATOR
  • Flemming Konradsen

    University of Copenhagen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2010

First Posted

June 17, 2010

Study Start

December 1, 2010

Primary Completion

May 1, 2013

Study Completion

June 1, 2016

Last Updated

July 18, 2019

Results First Posted

July 5, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations