Clinical trial NCT00142246: Study of the Impact of Intermittent Preventive Treatment in Schools on Malaria, Anaemia and Education.
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malaria, Falciparum
Keywords: malaria
anaemia
school performance
education
intermittent preventive treatment
schools
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: University of Nairobi
First posted: 2005-09-02
Enrollment: 6758
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study seeks to establish whether intermittent preventive treatment (IPT) can reduce malaria among school-going children and its consequent impact on school performance.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of anaemia (Hb <112g/L)
timeFrame: March 2006
Secondary outcomes:
measure: Prevalence of Plasmodium falciparum parasitaemia
timeFrame: March 2006
measure: Sustained attention
timeFrame: March 2006
measure: Mean haemoglobin
timeFrame: March 2006
Other outcomes:
Locations:
city: Bondo
country: Kenya
facility: Primary schools within Bondo district / Bondo District Hospital
state: Bondo district
Study officials:
affiliation: London School of Hygiene and Tropical Medicine, University of London, UK
name: Sian E Clarke, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: London School of Hygiene and Tropical Medicine, University of London, UK
name: Simon J Brooker, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nairobi
name: Benson BA Estambale, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Partnership for Child Development, Imperial College, University of London, UK
name: Matthew CH Jukes, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: DBL - Institute for Health Research and Development, Denmark
name: Pascal Magnussen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.