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LACK OF INHIBITION OF THE ANTI-MALARIAL ACTION OF SULFADOXINE-PYRIMETHAMINE BY FOLIC ACID SUPPLEMENTATION WHEN USED FOR INTERMITTENT PREVENTIVE TREATMENT IN GAMBIAN PRIMIGRAVIDAE

Folic acid is frequently given to pregnant women at the same time as intermittent preventive treatment (IPTp) with sulfadoxine/pyrimethamine (SP), but it is not known if it interferes with the anti-malarial activity of SP. To investigate this concern, 1,035 Gambian primigravidae were randomized to receive either folic acid (500–1,500 µg/day) together with oral iron (522) or oral iron alone (513) for 14 days at the same time as they received IPTp with SP. On presentation, 261 women (25%) had Plasmodium falciparum asexual parasitemia. Prevalences of parasitemia on day 14 after treatment were similar in both groups: 5.7% (26 of 458) in the iron plus folic acid group and 4.9% (22 of 446) in the iron alone group (risk difference = 0.74%, 95% confidence interval [CI] = –2.2% to 3.7%). Parasitologic cure was observed in 116 (91%) of 128 of women who were parasitemic on presentation and who received iron and folic acid and in 122 (92%) of 133 women who received iron alone (difference = 1.1%, 95% CI = –5.6% to 8.0%). Women who received folic acid and iron had a slightly higher mean hemoglobin concentration at day 14 than women who had received iron alone (difference = 0.14 g/dL, 95% CI = 0.01–0.27 g/dL). The results of this study suggest that in an area of low SP resistance, administration of folic acid to pregnant women in a dose of 500–1,500 µg/day will not interfere with the protective effect of SP when used for IPTp.

Received August 19, 2005. Accepted for publication February 23, 2006.

Acknowledgments: We thank the women who agreed to participate in this study. We also thank Sana Jawara (Divisional Health Office, Lower River Division); field supervisors Fabakaray Sanyang, Momodou Jobe, and Faramba Ceesay; and the many field assistants and laboratory staff who contributed to the trial; the members of the DSMB (Dr. Aggrey Oloo, Professor B. J. Brabin, Dr. K. Bojang, and Dr. D. M. Schellenberg) for their help with the project; and Dr. Harparkash Kaur for undertaking the high-performance liquid chromatography analyses. The support of Margaret Pinder in the supervision of laboratory staff and the support of the administrative staff of the MRC Laboratories (Banjul, The Gambia) is gratefully acknowledged.

Financial support: This study was supported by the Medical Research Council and the Gates Malaria Partnership, which receives funding from the Bill & Melinda Gates Foundation.

^* Address correspondence to Brian Greenwood, Department of Infectious and Tropical Diseases. London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, United Kingdom. E-mail: brian.greenwood{at}lshtm.ac.uk

Authors’ addresses: Amadou Mbaye, Sam Dunyo, and Gijs Walraven, Medical Research Council Laboratories, Banjul, The Gambia. Keshena Richardson, Caroline Shulman, Paul Milligan, and Brian Greenwood, Department of Infectious and Tropical Diseases. London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, United Kingdom. Baba Balajo, Department of Health, The Government of The Gambia, Banjul, The Gambia.