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A randomized controlled trial of folate supplementation when treating malaria in pregnancy with sulfadoxine-pyrimethamine

Ouma, Peter; Parise, Monica E.; Hamel, Mary J.; ter Kuile, Feiko O.; Otieno, Kephas; Ayisi, John G.; Kager, Piet A; Steketee, Richard W.; Slutsker, Laurence and van Eijk, Anna M. (2006) A randomized controlled trial of folate supplementation when treating malaria in pregnancy with sulfadoxine-pyrimethamine. PLoS Clinical Trials, 1 (6). Article Number: e28. 0001-0009. ISSN 1555-5887

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Abstract

Objectives Sulfadoxine-pyrimethamine (SP) is an antimalarial drug that acts on the folate metabolism of the malaria parasite. We investigated whether folate (FA) supplementation in a high or a low dose affects the efficacy of SP for the treatment of uncomplicated malaria in pregnant women. Design This was a randomized, placebo-controlled, double-blind trial. Setting The trial was carried out at three hospitals in western Kenya. Participants The participants were 488 pregnant women presenting at their first antenatal visit with uncomplicated malaria parasitaemia (density of ≥ 500 parasites/μl), a haemoglobin level higher than 7 g/dl, a gestational age between 17 and 34 weeks, and no history of antimalarial or FA use, or sulfa allergy. A total of 415 women completed the study. Interventions All participants received SP and iron supplementation. They were randomized to the following arms: FA 5 mg, FA 0.4 mg, or FA placebo. After 14 days, all participants continued with FA 5 mg daily as per national guidelines. Participants were followed at days 2, 3, 7, 14, 21, and 28 or until treatment failure. Outcome Measures The outcomes were SP failure rate and change in haemoglobin at day 14. Results The proportion of treatment failure at day 14 was 13.9% (19/137) in the placebo group, 14.5% (20/138) in the FA 0.4 mg arm (adjusted hazard ratio [AHR], 1.07; 98.7% confidence interval [CI], 0.48 to 2.37; p = 0.8), and 27.1% (38/140) in the FA 5 mg arm (AHR, 2.19; 98.7% CI, 1.09 to 4.40; p = 0.005). The haemoglobin levels at day 14 were not different relative to placebo (mean difference for FA 5 mg, 0.17 g/dl; 98.7% CI, −0.19 to 0.52; and for FA 0.4 mg, 0.14 g/dl; 98.7% CI, −0.21 to 0.49). Conclusions Concomitant use of 5 mg FA supplementation compromises the efficacy of SP for the treatment of uncomplicated malaria in pregnant women. Countries that use SP for treatment or prevention of malaria in pregnancy need to evaluate their antenatal policy on timing or dose of FA supplementation.

Item Type:Article
Additional Information:Published: October 20, 2006. Citation: Ouma P, Parise ME, Hamel MJ, ter Kuile FO, Otieno K, et al. (2006) A randomized controlled trial of folate supplementation when treating malaria in pregnancy with sulfadoxine-pyrimethamine. PLoS Clin Trials 1(6): e28. DOI: 10.1371/ journal.pctr.0010028
Uncontrolled Keywords:PARASITE PLASMODIUM-FALCIPARUM; ANTIFOLATE DRUG SYNERGY; FOLIC-ACID; ANTIMALARIAL THERAPY; ANEMIA; KENYA; PREVALENCE; PREVENTION; RESISTANCE; CHILDREN
Subjects:R Medicine > R Medicine (General)
Departments, Research Centres and Related Units:Academic Faculties, Institutes and Research Centres > Liverpool School of Tropical Medicine
DOI:10.1371/journal.pctr.0010028
Publisher's Statement:This is an open-access article distributed under the terms of the Creative Commons Public Domain declaration which stipulates that, once placed in the public domain, this work may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose.
Related URLs:
Refereed:Yes
Status:Published
ID Code:835
Deposited On:24 Jul 2008 15:11
Last Modified:15 Apr 2013 16:49

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