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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00142246
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : January 26, 2017
Sponsor:
Collaborator:
University of Nairobi
Information provided by (Responsible Party):
Brian Greenwood, London School of Hygiene and Tropical Medicine

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : January 2005
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Malaria

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Prevalence of anaemia (Hb <112g/L) [ Time Frame: March 2006 ]

Secondary Outcome Measures :
  1. Prevalence of Plasmodium falciparum parasitaemia [ Time Frame: March 2006 ]
  2. Sustained attention [ Time Frame: March 2006 ]
  3. Mean haemoglobin [ Time Frame: March 2006 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00142246


Locations
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Kenya
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
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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
More Information
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Publications:
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.
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Brian Greenwood, Professor, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00142246    
Other Study ID Numbers: ITDCVG41
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017
Keywords provided by Brian Greenwood, London School of Hygiene and Tropical Medicine:
malaria
anaemia
school performance
 education
intermittent preventive treatment
schools
Additional relevant MeSH terms:
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Malaria
Malaria, Falciparum
Anemia
Hematologic Diseases
Protozoan Infections
Parasitic Diseases
Infections
 Vector Borne Diseases
Amodiaquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents