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Completed

NCT Number: NCT00142246

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

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Primary schools within Bondo district / Bondo District Hospital

Bondo, Bondo District, Kenya

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent preventive treatment (SP and amodiaquine)

Drug

Oral medication. SP: single dose given over one day; amodiaquine: 3 daily doses over 3 days. Dosage has given according to age.

Placebo

Other

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

Primary outcomes

  1. Prevalence of anaemia (Hb <112g/L)

    Time frame: March 2006

Secondary outcomes

  1. Prevalence of Plasmodium falciparum parasitaemia

    Time frame: March 2006

  2. Sustained attention

    Time frame: March 2006

  3. Mean haemoglobin

    Time frame: March 2006

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Collaborators

  • University of Nairobi

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 2, 2005
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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