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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: SLCTR
Last refreshed on: 27 April 2013
Main ID:  SLCTR/2009/009
Date of registration: 18/09/2009
Primary sponsor: Faculty of Medicine, University of Kelaniya
Public title: The effect of deworming and iron supplementation on the learning ability of school children in the plantation sector of Sri Lanka
Scientific title: The impact of school-based de-worming and iron supplementation on the cognitive abilities of school children in the plantation sector of Sri Lanka
Date of first enrolment: 14/9/2009
Target sample size: 2000 children
Recruitment status: Completed
URL:  http://www.slctr.lk/trial_details.asp?reg_id={46F2BC2A-E495-4FA9-8E99-5E517115B9A7}
Study type:  Interventional
Study design:  A stratified, cluster randomized, controlled trial of the impact of de-worming and iron supplementation on the cognitive abilities and educational achievement of school going children  
Countries of recruitment
Sri Lanka
Contacts
Name: Nilanthi de Silva 
Address:  Dept of Parasitology, Faculty of Medicine, University of Kelaniya, PO Box 6 Ragama
Telephone: 2961143
Email: nrdes@sltnet.lk
Affiliation:  Professor of Parasitology
Name: Nilanthi de Silva 
Address:  Faculty of Medicine, Talagolla Road, Ragama
Telephone: 2961143
Email: nrdes@sltnet.lk
Affiliation:  Professor
Key inclusion & exclusion criteria
Inclusion criteria: 1. Estate schools with >60 and less than400 children.
2. Children attending Grade 4 in the selected schools

Exclusion criteria: Children with Hb level less than 7.0 g/L

Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Soil-transmitted helminth infections, iron deficiency anaemia, cognitive ability
Intervention(s)
Children in the treatment schools will be given an anthelmintic (mebendazole 500 mg stat) and weekly iron supplements (300 mg ferrous sulphate tablets) during the 2 school terms between the baseline and follow-up assessments (total of 20 tablets). Children in the control group will be given placebo tablets
Primary Outcome(s)
Prevalence of anaemia (Hbless than11.0 g/L)
Secondary Outcome(s)
1. Prevalence and intensity of soil-transmitted helminth infections

2. Mean Hb concentration

3. Sustained attention

4. Educational achievement
Secondary ID(s)
Nil known
Source(s) of Monetary Support
Partnership for Child Development, Imperial College, London, UK
Secondary Sponsor(s)
Partnership for Child Development
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