Study of the Impact of Intermittent Preventive Treatment in Schools on Malaria, Anaemia and Education.
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|ClinicalTrials.gov Identifier: NCT00142246|
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : January 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Malaria, Falciparum||Drug: Intermittent preventive treatment (SP and amodiaquine) Other: Placebo||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||6758 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
Three doses given over three days (Day 1: placebo SP + placebo AQ; Days 2 and 3: placebo AQ). Dosage given according to age
- Prevalence of anaemia (Hb <112g/L) [ Time Frame: March 2006 ]
- Prevalence of Plasmodium falciparum parasitaemia [ Time Frame: March 2006 ]
- Sustained attention [ Time Frame: March 2006 ]
- Mean haemoglobin [ Time Frame: March 2006 ]
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
|Primary schools within Bondo district / Bondo District Hospital|
|Bondo, Bondo district, Kenya|
|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|