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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
ISRCTN ISRCTN44215995
DOI 10.1186/ISRCTN44215995
ClinicalTrials.gov identifier
EudraCT number
Public title 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
Scientific title
Acronym N/A
Serial number at source N/A
Study hypothesis Deworming does not increase the incidence of malaria or the frequency of malaria attacks in pre-school children.
Lay summary
Ethics approval 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)
Study design Double-blind placebo-controlled randomised trial
Countries of recruitment Nigeria
Disease/condition/study domain Malaria, helminth parasitisation
Participants - inclusion criteria Pre-school children aged 12 - 59 months, either sex
Participants - exclusion criteria 1. Severe anaemia less than 5 g/dl
2. Severe malaria
Anticipated start date 16/05/2006
Anticipated end date 22/08/2007
Status of trial Completed
Patient information material
Target number of participants 1055
Interventions 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.
Primary outcome measure(s) 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
Secondary outcome measure(s) 1. Nutritional status, measured at baseline and 14 months
2. Haemoglobin, measured at baseline and 4, 8, 12 and 14 months
Sources of funding Health Research Board (HRB) (Ireland)
Trial website
Publications 2009 anthelmintic results in http://www.ncbi.nlm.nih.gov/pubmed/19228385
Contact name Prof  Celia  Holland
  Address Department of Zoology
The University of Dublin
Trinity College
  City/town Dublin
  Zip/Postcode 02
  Country Ireland
Sponsor The University of Dublin (Ireland)
  Address Trinity College
  City/town Dublin
  Zip/Postcode 02
  Country Ireland
  Sponsor website: http://www.tcd.ie/
Date applied 28/07/2008
Last edited 16/04/2010
Date ISRCTN assigned 25/09/2008
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