Study of the Impact of Intermittent Preventive Treatment in Schools on Malaria, Anaemia and Education.

Malaria, Falciparum Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00142246
• Other study ID #: ITDCVG41
• Status: Completed
• Phase: Phase 3
• First received: August 31, 2005
• Last updated: January 25, 2017
• Start date: January 2005
• Est. completion date: April 2006

Study information

• Verified date: January 2017
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6758
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Malaria
• Malaria, Falciparum

Intervention

Drug:
• Intermittent 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.

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

Locations

Country	Name	City	State
Kenya	Primary schools within Bondo district / Bondo District Hospital	Bondo	Bondo district

Sponsors (2)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	University of Nairobi

Country where clinical trial is conducted

Kenya, 

References & Publications (2)

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, 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of anaemia (Hb <112g/L)		March 2006
Secondary	Prevalence of Plasmodium falciparum parasitaemia		March 2006
Secondary	Sustained attention		March 2006
Secondary	Mean haemoglobin		March 2006