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ClinicalTrials.gov Identifier: NCT00131716
: August 19, 2005
Last Update Posted
: January 12, 2017
London School of Hygiene and Tropical Medicine
Department of State for Health and Social Welfare, The Gambia
Information provided by (Responsible Party):
Brian Greenwood, London School of Hygiene and Tropical Medicine
Severe anaemia is a frequent cause of admission to hospitals in tropical Africa and about 10% of such children die. In endemic countries, anaemia has multiple causes such as nutritional deficiencies, infections and haemoglobinopathies. However, Plasmodium falciparum infection is believed to be the major contributory factor to the aetiology of severe anaemia. Severe anaemia is usually treated by blood transfusion although transfusion carries the attendant risk of transmission of HIV and other blood-borne infections. Thus, there is a need to explore novel strategies to reduce the incidence of severe anaemia in high-risk groups such as children with suboptimal haemoglobin levels because these children are at increased risk of developing severe anaemia if they develop a malaria infection before their haemoglobin level has normalized. Therefore, it is proposed to study whether monthly chemoprophylaxis with sulphadoxine/pyrimethamine (S/P) given during malaria transmission season can protect Gambian children from developing severe anaemia. After receiving treatment from the hospital, 1200 children admitted to the hospital with a haematocrit of less than 21% were randomised to receive either monthly S/P or placebo during the rest of the malaria transmission season. Morbidity was monitored throughout the rainy season. Study subjects were seen at the end of the dry season to document morbidity and mortality.
Proportion of children with moderate anaemia (hemoglobin [Hb] <7 g/dl [ Time Frame: at end of the malaria transmission season ]
haemoglobin concentration [ Time Frame: At the end of malaria transmission season ]
hemoglobin concentration [ Time Frame: at the end of malaria transmission season ]
Secondary Outcome Measures
Proportion of children with anaemia (Hb <11g/dl) and those with severe anaemia (Hb <5 g/dl) [ Time Frame: at end of the malaria transmission season ]
Mean Hb : Difference between S/P and placebo, Difference between S/P and placebo adjusted for baseline Hb and other covariates [ Time Frame: at the end of the malaria transmission season ]
Number of outpatient department (OPD) attendances with malaria [ Time Frame: during the surveillance period ]
Number of hospital admissions with malaria [ Time Frame: during the surveillance period ]
Number of episodes of severe malaria [ Time Frame: during the surveillance period ]
Deaths (all-cause and malaria-specific) [ Time Frame: during the surveillance period ]
Adherence to the study regimen: The number of doses of medication received by children in each group as a proportion of the total number of doses that should have been received [ Time Frame: during the study period ]
OPD attendance with malaria [ Time Frame: during the surveillance period ]
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Ages Eligible for Study:
3 Months to 9 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Age: 3 months to 9 years.
Haemoglobin concentration 7g/dl on admission to hospital.
Residence within 30 km of the study centre and availability for the duration of the study period.
Informed consent to participate in the study given by the parent or guardian.