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ISRCTN
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ISRCTN44215995
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DOI
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10.1186/ISRCTN44215995
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Effect of repeated four-monthly albendazole treatments on malaria in pre-school children living in communities endemic for Ascaris lumbricoides: a double-blind placebo-controlled randomised trial
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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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Deworming does not increase the incidence of malaria or the frequency of malaria attacks in pre-school children.
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Lay summary
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Ethics approval
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The Ethics and Research Committee of Obafemi Awolowo University Teaching Hospitals' Complex (Nigeria) gave approval on the 13th April 2006 (ref: ERC/2006/03/16)
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Study design
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Double-blind placebo-controlled randomised trial
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Countries of recruitment
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Nigeria
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Disease/condition/study domain
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Malaria, helminth parasitisation
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Participants - inclusion criteria
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Pre-school children aged 12 - 59 months, either sex
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Participants - exclusion criteria
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1. Severe anaemia less than 5 g/dl
2. Severe malaria
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Anticipated start date
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16/05/2006
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Anticipated end date
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22/08/2007
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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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1055
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Interventions
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There were two groups: the treatment (albendazole) group and the placebo group. A dose of 200 mg (one tablet) of albendazole was given to children aged 1 year. A dose of 400 mg (two tablets) of albendazole was given to children aged 2, 3 and 4 years. Children who were in the placebo group and aged 1 year were given one placebo tablet and children aged 2, 3 and 4 years were given two placebo tablets.
Children were given treatment or placebo at baseline, 4, 8 and 12 months and then followed up for the last time at 14 months. Children in the placebo group were treated with albendazole at 14 months.
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Primary outcome measure(s)
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1. Incidence of malaria, measured at baseline and 4, 8, 12 and 14 months
2. Malaria attacks, measured at baseline and 4, 8, 12 and 14 months
3. Infection with soil-transmitted helminths, measured at baseline and 4, 8, 12 and 14 months
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Secondary outcome measure(s)
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1. Nutritional status, measured at baseline and 14 months
2. Haemoglobin, measured at baseline and 4, 8, 12 and 14 months
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Sources of funding
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Health Research Board (HRB) (Ireland)
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Trial website
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Publications
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2009 anthelmintic results in http://www.ncbi.nlm.nih.gov/pubmed/19228385
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Contact name
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Prof
Celia
Holland
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Address
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Department of Zoology
The University of Dublin
Trinity College
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City/town
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Dublin
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Zip/Postcode
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02
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Country
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Ireland
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Sponsor
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The University of Dublin (Ireland)
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Address
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Trinity College
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City/town
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Dublin
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Zip/Postcode
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02
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Country
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Ireland
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Sponsor website:
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http://www.tcd.ie/
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Date applied
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28/07/2008
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Last edited
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16/04/2010
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Date ISRCTN assigned
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25/09/2008
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