| Scientific Title of Trial | The impact of school-based de-worming and iron supplementation on the cognitive abilities of school children in the plantation sector of Sri Lanka | |
| Public Title of Trial (in lay language) | The effect of deworming and iron supplementation on the learning ability of school children in the plantation sector of Sri Lanka | |
| Acronym, if any | None | |
| Brief title, if any | None | |
| Any
other number(s) assigned to the trial and issuing authoruty, if any (eg. sponsor, other trial registry) |
Nil known | |
| Disease or Health Condition(s) studied | Soil-transmitted helminth infections, iron deficiency anaemia, cognitive ability | |
| What is the research question being addressed? | 1. What is the current prevalence of infection Ascaris lumbricoides, Trichuris trichiura and Necator americanus, and of anaemia among children attending plantation sector schools in the districts of Badulla, Kandy, Kegalle and Ratnapura? 2. What is the impact of school-based deworming treatment and iron supplementation on the cognitive functions, namely concentration levels, and educational achievement of these children? | |
| 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 | |
| Intervention(s) planned | 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 | |
| Inclusion criteria | 1. Estate schools with >60 and <400 children. 2. Children attending Grade 4 in the selected schools | |
| Exclusion criteria | Children with Hb level < 7.0 g/L | |
| Target number / sample size | 2000 children | |
| Primary outcome(s) | Prevalence of anaemia (Hb<11.0 g/L) | |
| Primary outcome(s) - time of assessment(s) | 6-months follow-up survey | |
| Secondary outcome(s) | 1. Prevalence and intensity of soil-transmitted helminth infections 2. Mean Hb concentration 3. Sustained attention 4. Educational achievement |
|
| Secondary outcome(s) - time of assessment(s) | 6-months follow-up survey | |
| Countries of recruitment | Sri Lanka | |
| Anticipated start date | 14/09/2009 | |
| Anticipated end date | 31/07/2010 | |
| Recruitment status | Completed | |
| State of ethics review approval | Ethical Review Committee approval obtained from Ethical Review Committee, Faculty of Medicine, University of Kelaniya | |
| Funding source(s) | Partnership for Child Development, Imperial College, London, UK | |
| Applicant's Email | nrdes@sltnet.lk | |
| Approval Status | Approved | |
| Contact Person for Scientific Queries / Principal investigator | Nilanthi de Silva
Professor of Parasitology Dept of Parasitology, Faculty of Medicine, University of Kelaniya, PO Box 6 Ragama 2961143 2958337 nrdes@sltnet.lk |
|
| Primary Study Sponsor/ Organization | Faculty of Medicine, University of Kelaniya
Talagolla Road, Ragama 2961000 2958337 www.mfac.kln.ac.lk |
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| Contact Person for Public Queries | Nilanthi de Silva Professor Faculty of Medicine, Talagolla Road, Ragama 2961143 2958337 nrdes@sltnet.lk |
|
| Secondary Study Sponsor(s), (if any) | Partnership for Child Development Dept. of Infectious Disease Epidemiology, Imperial College Faculty of Medicine, Norfolk Place London +44(0)2075943257 +44(0)2072627912 anthi.patrikios@imperial.ac.uk www.child-development.org |
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