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

This study has been completed.
Sponsor:
Collaborator:
University of Nairobi
Information provided by:
Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00142246
First received: August 31, 2005
Last updated: February 7, 2008
Last verified: February 2008
History of Changes

August 31, 2005
February 7, 2008
January 2005
April 2006   (final data collection date for primary outcome measure)
Prevalence of anaemia (Hb <112g/L) [ Time Frame: March 2006 ] [ Designated as safety issue: No ]
  • Prevalence of anaemia (Hb <112g/L)
  • Mean haemoglobin (Hb)
Complete list of historical versions of study NCT00142246 on ClinicalTrials.gov Archive Site
  • Prevalence of Plasmodium falciparum parasitaemia [ Time Frame: March 2006 ] [ Designated as safety issue: No ]
  • Sustained attention [ Time Frame: March 2006 ] [ Designated as safety issue: No ]
  • Mean haemoglobin [ Time Frame: March 2006 ] [ Designated as safety issue: No ]
  • Prevalence of Plasmodium falciparum parasitaemia
  • Sustained attention
Not Provided
Not Provided
 
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

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

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Malaria, Falciparum
  • 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
  • Experimental: 1
    Intermittent preventive treatment with antimalarial drug combination(SP and amodiaquine)
    Intervention: Drug: Intermittent preventive treatment (SP and amodiaquine)
  • Placebo Comparator: 2
    Dual placebo comparator
    Intervention: Other: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6758
April 2006
April 2006   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT00142246
ITDCVG41
Yes
Not Provided
Gates Malaria Partnership
University of Nairobi
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
Gates Malaria Partnership
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP