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

January 25, 2017 updated by: Brian Greenwood, London School of Hygiene and Tropical Medicine

Intermittent Preventive Treatment in Schools: a Randomised Controlled Trial of the Impact of IPT on Malaria, Anaemia and Education Amongst Schoolchildren in Western Kenya

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

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

6758

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
    • Bondo district
      • Bondo, Bondo district, Kenya
        • Primary schools within Bondo district / Bondo District Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
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

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

This is where you will find people and organizations involved with this study.

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

University of Nairobi

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

August 31, 2005

First Submitted That Met QC Criteria

August 31, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Estimate)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

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.

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