A Randomized Controlled Trial of Folate Supplementation When Treating Malaria in Pregnancy with Sulfadoxine-Pyrimethamine
2006

Folate Supplementation and Malaria Treatment in Pregnant Women

Sample size: 488 publication Evidence: high

Author Information

Author(s): 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, van Eijk Anna M

Primary Institution: Centre for Vector Biology and Control Research, Kenya Medical Research Institute

Hypothesis

Does folate supplementation in high or low doses affect the efficacy of sulfadoxine-pyrimethamine for treating uncomplicated malaria in pregnant women?

Conclusion

Folate supplementation at 5 mg compromises the efficacy of sulfadoxine-pyrimethamine for treating uncomplicated malaria in pregnant women.

Supporting Evidence

  • Women receiving folate 5 mg daily were approximately twice as likely to fail treatment with sulfadoxine-pyrimethamine than those receiving lower doses.
  • Overall, around 27% of women receiving folate 5 mg had treatment failure during the follow-up period.
  • All treatment groups had similar levels of blood hemoglobin at the end of the study.
  • No major differences in adverse events were observed among the different study groups.

Takeaway

Giving pregnant women a high dose of folate while treating malaria can make the treatment less effective. A lower dose of folate might be better.

Methodology

This was a randomized, placebo-controlled, double-blind trial conducted at three hospitals in western Kenya.

Potential Biases

The study used appropriate randomization and blinding procedures, reducing the risk of bias.

Limitations

The short duration of the intervention and lack of PCR genotyping on parasites limited the ability to distinguish between treatment failures and new infections.

Participant Demographics

Participants were 488 pregnant women with uncomplicated malaria, aged between 17 and 34 weeks of gestation.

Statistical Information

P-Value

0.005

Confidence Interval

98.7% CI, 1.09 to 4.40

Statistical Significance

p = 0.005

Digital Object Identifier (DOI)

10.1371/journal.pctr.0010028

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