title: A randomised, double-blind, placebo-controlled clinical trial of vitamin A in severe malaria in hospitalised Mozambican children.
abstract: This paper reports a randomised, double-blind, placebo-controlled clinical trial of the effect of routine vitamin A supplementation given on admission to children with severe malaria with regard to survival, recovery during hospitalisation and outcome 6 weeks after discharge. Children aged between 6 and 72 months admitted to the paediatric wards of the Central Hospital of Maputo (CHM), Mozambique with a diagnosis of severe malaria were randomly assigned either to a control group (placebo) or an experimental group (vitamin A) and were followed up 6 weeks after discharge. There were 280 children in the experimental and 290 in the placebo group. Seven (2.5%) and 13 (4.5%) children died in the experimental and the placebo groups, respectively, a relative risk of death of 0.56 (95% CI 0.23-1.38, p = 0.201). During the 1st 5 hours of admission, the relative risk of death in the vitamin A-supplemented group was 2.54 (0.50-12.96); after 5 hours of admission it was 0.19 (95% CI 0.04-0.85; p = 0.015). In the supplemented group, 4/82 (4.9%) of the children developed neurological sequelae vs 2/78 (2.6%) in the placebo group (RR = 1.90; 95% CI 0.36-10.09; p = 0.682). Although the overall reduction in the risk of death observed for all children receiving vitamin A is not statistically significant, it might be clinically important. This finding cannot, however, be accepted as a firm conclusion and requires validation by future trials.
authors.affiliation: Health Systems Unit and Centre for Malaria and other Tropical Diseases, Institute of Hygiene and Tropical Medicine, New University of Lisbon, Portugal. varandas@ihmt.unl.pt
authors.forename: L
authors.initials: L
authors.lastname: Varandas
authors.forename: M
authors.initials: M
authors.lastname: Julien
authors.forename: A
authors.initials: A
authors.lastname: Gomes
authors.forename: P
authors.initials: P
authors.lastname: Rodrigues
authors.forename: W
authors.initials: W
authors.lastname: Van Lerberghe
authors.forename: F
authors.initials: F
authors.lastname: Malveiro
authors.forename: P
authors.initials: P
authors.lastname: Aguiar
authors.forename: P
authors.initials: P
authors.lastname: Kolsteren
authors.forename: P
authors.initials: P
authors.lastname: Van Der Stuyft
authors.forename: K
authors.initials: K
authors.lastname: Hilderbrand
authors.forename: D
authors.initials: D
authors.lastname: Labadarios
authors.forename: P
authors.initials: P
authors.lastname: Ferrinho
mesh_terms: D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006760:Hospitalization; D006801:Humans; D007223:Infant; D007902:Length of Stay; D016779:Malaria, Cerebral / Q000188:drug therapy; D016778:Malaria, Falciparum / Q000188:drug therapy*; D008297:Male; D015996:Survival Rate; D016896:Treatment Outcome; D014801:Vitamin A / Q000627:therapeutic use*
chemical_list: D014801:Vitamin A