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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00142246
Enrollment
6758
Registered
2005-09-02
Start date
2005-01-31
Completion date
2006-04-30
Last updated
2017-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria, Falciparum

Keywords

malaria, anaemia, school performance, education, intermittent preventive treatment, schools

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.

Interventions

DRUGIntermittent preventive treatment (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.

OTHERPlacebo

Three doses given over three days (Day 1: placebo SP + placebo AQ; Days 2 and 3: placebo AQ). Dosage given according to age

Sponsors

University of Nairobi
CollaboratorOTHER
London School of Hygiene and Tropical Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Prevalence of anaemia (Hb <112g/L)March 2006

Secondary

MeasureTime frame
Prevalence of Plasmodium falciparum parasitaemiaMarch 2006
Sustained attentionMarch 2006
Mean haemoglobinMarch 2006

Countries

Kenya

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026