Home » Trials » SLCTR/2009/009
The impact of school-based de-worming and iron supplementation on the cognitive abilities of school children in the plantation sector of Sri Lanka
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SLCTR Registration Number
SLCTR/2009/009
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
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
The effect of deworming and iron supplementation on the learning ability of school children in the plantation sector of Sri Lanka
Disease or Health Condition(s) Studied
Soil-transmitted helminth infections, iron deficiency anaemia, cognitive ability
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
P103/08/2009 (Ethics Review Committee of the Faculty of Medicine, University of Kelaniya)
What is the research question being addressed?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
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
Exclusion criteria
Children with Hb level < 7.0 g/L
Primary outcome(s)
|
1.
Prevalence of anaemia (Hb<11.0 g/L) |
[ 6-months follow-up survey ] |
Secondary outcome(s)
|
1.
|
[ 6-months follow-up survey ] |
Target number/sample size
2000
Countries of recruitment
Sri Lanka
Anticipated start date
2009-09-14
Anticipated end date
2010-07-31
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
Partnership for Child Development, Imperial College, London, UK
Regulatory approvals
Status
Approved
Date of Approval
2009-08-25
Approval number
P103/08/2009
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
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
Contact Person for Public Queries
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
Secondary study sponsor (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
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
