| dc.contributor.author | Peter Ouma, Monica E Parise, Mary J Hamel, Feiko O Ter Kuile, Kephas Otieno, John G Ayisi, Piet A Kager, Richard W Steketee, Laurence Slutsker, Anna M Van Eijk | |
| dc.description.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/ll), 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; p¼0.8), and 27.1% (38/140) in the FA 5 mg arm (AHR, 2.19;
98.7% CI, 1.09 to 4.40; p ¼ 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. | en_US |
