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ISRCTN
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ISRCTN42261314
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ClinicalTrials.gov identifier
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Public title
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Insecticide Treated bedNets (ITNs) for malaria control in Urban Accra
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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The main objectives of the study:
1. Assess if bednets can be used as rapid, high coverage control method for malaria in urban areas
2. Investigate the effect of ITN introduction on malaria, anaemia and anthropometric measurements
3. Assess the use of haemoglobin level as a measurement of intervention efficacy by controlling for nutritional and geohelminth confounding factors
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Ethics approval
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1. Liverpool School of Tropical Medicine, UK, approved on 23 September 2002 (ref: 02:50). Some amendments to the existing clearance were reviewed on the 30 April 2004 with additional approval granted on 3rd June 2004.
2. Noguchi Memorial Institute for Medical Research, University of Ghana, Legon, ethical clearance granted in September 2002
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Study design
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Non-randomised controlled trial
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Countries of recruitment
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Ghana
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Disease/condition/study domain
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Malaria and anaemia
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Participants - inclusion criteria
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Children aged over 1 month and under 10 years
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Participants - exclusion criteria
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Children with haemoglobin (Hb) <8g/dl who will require iron supplementation
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Anticipated start date
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20/05/2004
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Anticipated end date
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17/12/2004
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Status of trial
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Completed
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Patient information material
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Target number of participants
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600
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Interventions
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Insecticide treated bednets vs no intervention (Control group received bednets after six months)
It was not possible to randomly allocate children to the two arms of the study as the intervention was community based. The insecticide treated nets were distributed in the intervention community and therefore all children surveyed in that community entered the intervention arm. All households with children under 10 and/or pregnant women in the control community received an insecticide treated nets after six months.
Duration of intervention: 6 months (although the insecticide treated nets remained the property of the study subjects)
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Primary outcome measure(s)
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The following were assessed at enrolment, 3 and 6 months:
1. Moderate anaemia, provisionally defined as a haemoglobin level <9 g/dl
2. Haemoglobin level as a continuous variable (in g/dl)
3. Density of infection defined as parasitaemia >5,000 parasites/mm3
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Secondary outcome measure(s)
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None
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Sources of funding
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The Department for International Development (DfID) Malaria Knowledge Programme of the Liverpool School of Tropical Medicine (UK)
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Trial website
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Publications
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Contact name
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Dr
Martin
Donnelly
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Address
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Liverpool School of Tropical Medicine
Pembroke Place
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City/town
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Liverpool
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Zip/Postcode
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L35QA
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Country
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United Kingdom
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Sponsor
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Liverpool School of Tropical Medicine (UK)
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Address
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c/o Dr Martin Donnelly
Pembroke Place
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City/town
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Liverpool
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Zip/Postcode
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L35QA
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Country
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United Kingdom
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Sponsor website:
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http://www.liv.ac.uk/lstm/
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Date applied
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31/01/2008
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Last edited
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04/04/2008
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Date ISRCTN assigned
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04/04/2008
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