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

Sponsor

London School of Hygiene and Tropical Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT00142246

Collaborator

University of Nairobi (Other)

6,758

Enrollment

Location

Arms

14.9

Duration (Months)

452.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malaria, Falciparum	Drug: Intermittent preventive treatment (SP and amodiaquine) Other: Placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

6758 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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 Start Date :

Jan 1, 2005

Actual Primary Completion Date :

Apr 1, 2006

Actual Study Completion Date :

Apr 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Intermittent preventive treatment with antimalarial drug combination(SP and amodiaquine)	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.
Placebo Comparator: 2 Dual placebo comparator	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

Arm

Intervention/Treatment

Experimental: 1

Intermittent preventive treatment with antimalarial drug combination(SP and amodiaquine)

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.

Placebo Comparator: 2

Dual placebo comparator

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

Outcome Measures

Primary Outcome Measures

Prevalence of anaemia (Hb <112g/L) [March 2006]

Secondary Outcome Measures

Prevalence of Plasmodium falciparum parasitaemia [March 2006]
Sustained attention [March 2006]
Mean haemoglobin [March 2006]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Primary schools within Bondo district / Bondo District Hospital	Bondo	Bondo district	Kenya

Sponsors and Collaborators

London School of Hygiene and Tropical Medicine
University of Nairobi

Investigators

Principal Investigator: Sian E Clarke, PhD, London School of Hygiene and Tropical Medicine, University of London, UK
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
Principal Investigator: Pascal Magnussen, MD, DBL - Institute for Health Research and Development, Denmark