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ISRCTN
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ISRCTN83830814
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DOI
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10.1186/ISRCTN83830814
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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 three-monthly albendazole treatments on malaria and allergic disease
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Scientific title
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Parasitic infections and Inflammatory Diseases: The web of immune responses, host genetics and environmental exposure
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Acronym
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N/A
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Serial number at source
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05-PP-35
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Study hypothesis
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Intestinal helminth infections suppress atopy and incidence of malaria and this suppression is reversible by antihelminthic treatment
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Lay summary
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Ethics approval
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University of Indonesia, approved on 11/09/2006 (ref: 194/ PT02.FK/Etik/2006)
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Study design
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Randomised double-blind placebo-controlled trial
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Countries of recruitment
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Indonesia
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Disease/condition/study domain
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Helminth and malaria parasitic diseases
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Participants - inclusion criteria
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1. Both males and females
2. Age >=2 years. No upper age limit.
3. Those who have given informed consent
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Participants - exclusion criteria
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1. History of chronic liver, heart or central nervous system (CNS) disease
2. Allergy to albendazole
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Anticipated start date
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01/11/2008
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Anticipated end date
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01/11/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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4,000
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Interventions
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400 mg albendazole (oral) or matching placebo every three months for 2 years.
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Primary outcome measure(s)
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1. Prevalence of malaria parasite, assessed throughout the study for 3 years
2. Infection with intestinal helminth before treatment and within 1, 2 and 3 years after start of treatment
3. Skin reactivity to allergens assessed before treatment and within 1, 2 and 3 years after start of treatment
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Secondary outcome measure(s)
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Immune response to malaria and helminth antigens, assessed before albendazole treatment and within 1, 2 and 3 years after the start of treatment (with the last treatment given at least 2 months before immunological determination).
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Sources of funding
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Royal Netherlands Academy of Arts and Sciences (Netherlands) (ref: 05-PP-35)
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Trial website
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Publications
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Contact name
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Prof
Maria
Yazdanbakhsh
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Address
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Department of Parasitology
Leiden University Medical Centre
Albinusdreef 2
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City/town
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Leiden
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Zip/Postcode
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2333 ZA
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Country
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Netherlands
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Email
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M.Yazdanbakhsh@lumc.nl
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Sponsor
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Royal Netherlands Academy of Arts and Sciences (Netherlands)
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Address
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Kloveniersburgwal 29
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City/town
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Amsterdam
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Zip/Postcode
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1011 JV
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Country
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Netherlands
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Email
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knaw@bureau.knaw.nl
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Sponsor website:
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http://www.knaw.nl
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Date applied
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08/12/2008
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Last edited
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27/02/2009
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Date ISRCTN assigned
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27/02/2009
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