Study of the Impact of Intermittent Preventive Treatment in Schools on Malaria, Anaemia and Education.
Intermittent Preventive Treatment in Schools: a Randomised Controlled Trial of the Impact of IPT on Malaria, Anaemia and Education Amongst Schoolchildren in Western Kenya
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Although the risk of malaria is greatest in early childhood, significant numbers of schoolchildren remain at risk from malaria-specific morbidity and mortality. Each year between 20-50% of schoolchildren, aged 10-14 years, living in malaria-endemic areas will experience a clinical attack of malaria (Clarke et al., 2004). Malaria accounts for 3-8% of all-cause absenteeism from school, and up to 50% of preventable absenteeism (Brooker et al., 2000). In addition, asymptomatic parasitaemia contributes to anaemia, reducing concentration and learning in the classroom (Holding & Snow, 2001). Intermittent preventive treatment (IPT) delivered through schools is a simple intervention, which can be readily integrated into broader school health programmes. This study seeks to examine whether IPT can reduce malaria and anaemia amongst school-going children, and its consequent impact on school performance, in order to assess its suitability for inclusion as a standard intervention in school health programmes.
The efficacy of IPT is being evaluated in schoolchildren with a high-level of acquired immunity and ability to limit parasite growth, in whom most infections are asymptomatic and may go untreated.
The intervention: Intermittent preventive treatment of malaria administered each school term with the purpose to reduce asymptomatic parasitaemia and prevent clinical attacks, thereby reducing anaemia and school absenteeism, with consequences for improved attendance and concentration in class.
Schools are randomly allocated to one of two arms:
- Intervention schools: IPT given three times a year (once per term) + mass treatment with anthelminthics
- Control schools: mass treatment with anthelminthics only
Mass treatment with anthelminthics is carried out in all study schools twice annually in accordance with national policy.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Bondo district
-
Bondo, Bondo district, Kenya
- Primary schools within Bondo district / Bondo District Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Enrolled in primary school, and attending regularly
- Enrolled in nursery or classes 1-7
- Informed consent from parent or guardian
Exclusion Criteria:
- Enrolled in primary class 8
- Haemoglobin level below 70g/L at baseline
- History of reaction to sulfa drugs (e.g. fansidar, septrin)
- History of severe skin reaction to any drug
Withdrawal criteria:
- Withdrawal of parental consent
- Haemoglobin level falling below 70g/L
- Severe adverse reaction to treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Intermittent preventive treatment with antimalarial drug combination(SP and amodiaquine)
|
Oral medication.
SP: single dose given over one day; amodiaquine: 3 daily doses over 3 days.
Dosage has given according to age.
|
|
Placebo Comparator: 2
Dual placebo comparator
|
Three doses given over three days (Day 1: placebo SP + placebo AQ; Days 2 and 3: placebo AQ).
Dosage given according to age
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Prevalence of anaemia (Hb <112g/L)
Time Frame: March 2006
|
March 2006
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Prevalence of Plasmodium falciparum parasitaemia
Time Frame: March 2006
|
March 2006
|
|
Sustained attention
Time Frame: March 2006
|
March 2006
|
|
Mean haemoglobin
Time Frame: March 2006
|
March 2006
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sian E Clarke, PhD, London School of Hygiene and Tropical Medicine, University of London, UK
- Principal Investigator: Pascal Magnussen, MD, DBL - Institute for Health Research and Development, Denmark
- Principal Investigator: Simon J Brooker, PhD, London School of Hygiene and Tropical Medicine, University of London, UK
- Principal Investigator: Benson BA Estambale, MBChB, PhD, University of Nairobi
- Principal Investigator: Matthew CH Jukes, PhD, Partnership for Child Development, Imperial College, University of London, UK
Publications and helpful links
General Publications
- Clarke SE, Brooker S, Jukes MCH, Njagi JK, Khasakhala L, Otido J, Crudder C, McGlone B, Magnussen P & Estambale BBA. (2006). Randomised controlled trial of intermittent preventive treatment in schoolchildren: Impact on malaria, anaemia & school performance [abstract]. American Journal of Tropical Medicine & Hygiene Suppl 75 (5): 123.
- Clarke S, Njagi J, Jukes M, Estambale B, Khasakhala L, Ajanga A, Luoba A, Otido J, Ochola S & Magnussen P. (2005). Intermittent preventive treatment in schools: Malaria parasitaemia, anaemia and school performance [abstract]. Acta Tropica, Suppl 95: S133.
- Clarke SE, Jukes MC, Njagi JK, Khasakhala L, Cundill B, Otido J, Crudder C, Estambale BB, Brooker S. Effect of intermittent preventive treatment of malaria on health and education in schoolchildren: a cluster-randomised, double-blind, placebo-controlled trial. Lancet. 2008 Jul 12;372(9633):127-138. doi: 10.1016/S0140-6736(08)61034-X. Erratum In: Lancet. 2009 Jan 3;373(9657):30.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ITDCVG41
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.