Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Deworming does not increase the incidence of malaria or the frequency of malaria attacks in pre-school children.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Malaria, helminth parasitisation
Intervention
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Albendazole
Primary outcome measure
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 measures
1. Nutritional status, measured at baseline and 14 months
2. Haemoglobin, measured at baseline and 4, 8, 12 and 14 months
Overall trial start date
16/05/2006
Overall trial end date
22/08/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Pre-school children aged 12 - 59 months, either sex
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
1055
Participant exclusion criteria
1. Severe anaemia less than 5 g/dl
2. Severe malaria
Recruitment start date
16/05/2006
Recruitment end date
22/08/2007
Locations
Countries of recruitment
Nigeria
Trial participating centre
Department of Zoology
Dublin
02
Ireland
Sponsor information
Organisation
The University of Dublin (Ireland)
Sponsor details
Trinity College
Dublin
02
Ireland
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Health Research Board (HRB) (Ireland)
Alternative name(s)
HRB
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Ireland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 anthelmintic results in http://www.ncbi.nlm.nih.gov/pubmed/19228385
Publication citations
-
Anthelmintic results
Kirwan P, Asaolu SO, Molloy SF, Abiona TC, Jackson AL, Holland CV, Patterns of soil-transmitted helminth infection and impact of four-monthly albendazole treatments in preschool children from semi-urban communities in Nigeria: a double-blind placebo-controlled randomised trial., BMC Infect. Dis., 2009, 9, 20, doi: 10.1186/1471-2334-9-20.