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M.N . Mwangi 1,2 , P. E. A. Andang’o, 1,2 A.M . Mwangi, 2 H.F.J. Savelkoul, 3 H . Verhoef, 3,4
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M.N. Mwangi1,2, P. E. A. Andang’o,1,2 A.M. Mwangi,2H.F.J. Savelkoul,3 H. Verhoef,3,4 1Department of Nutrition and Health, Maseno University, Maseno, Kenya, 2Applied Nutrition Programme, Department of Food Technology and Nutrition, University of Nairobi, Nairobi, Kenya, 3MRC International Nutrition Group, London School of Hygiene and Tropical Medicine, UK, 4Cell Biology and Immunology Group, Wageningen University, Wageningen, The Netherlands. Background and objectives: There are concerns that supplemental iron can lead to increased burden of malaria. Our study aimed to compare the presence of Plasmodium infection in parturient women who antenatallyreceived daily supplementation with iron versus placebo. Secondary objectives were: to assess intervention effects on neonatal iron stores at 1-month of age; to assess intervention effects on the maternal prevalence of iron deficiency anaemia at 1-month after delivery; and to assess intervention effects on maternal intestinal pathogens at 1-month after delivery. Safety and efficacy of ironsupplementation in Africanpregnantwomen: a randomised trial Methods: We conducted our study in Nyanza province, Kenya, from September 2011 to April 2013. Pregnant women with gestational age 16-23 weeks were randomly allocated to daily supplements with iron (60mg as ferrous fumarate) or placebo. Pregnancy was shown by the presence in urine of human chorionic gonadotropinand confirmed by obstetric ultrasound examination. Supplements were given in capsules to allow masking. In addition, to avoid severe anaemia, all women received a small daily dose of iron in the form of iron-fortified flour (target level: 20 mg/kg flour, as NaFeEDTA). The study (www.ClinicalTrials.gov: NCT01308112) received ethical clearance in Kenya and the UK. A research clinic was established where women could deliver, so that we could collect placental and blood samples. The intervention continued for 1 month post-partum, and blood samples so that we could assess intervention efficacy in maternal and neonatal blood samples collected at the end of the intervention. The primary outcome measure was maternal Plasmodium infection at parturition as assessed by LDH-based and HRP2-based dipstick tests and PCR. Iron status was assessed by plasma iron markers (ferritin and soluble transferrin receptor concentration). To account for the effect of inflammation on these markers, we also assessed plasma concentrations of C-reactive protein and α1-acid glycoprotein. Preliminaryresults: Invited (2,015) No show (211) Currently, all of the field work and 90% of the laboratory analysis have been completed. Data analysis and preparation of manuscripts are in progress. Figure 1 shows the participants’ flow in the trial. We excluded 1,334 of 1,804 screened women. Of 470 women who were randomised to intervention, 37% (8%) were lost for various reasons. We were successful in collecting placental and blood samples in 424 (90%) of women; in 9 (2%), we collected blood samples but not placental samples, because deliveries took place at home or at a referral hospital, where placentae were lost or discarded. At baseline, there was a high prevalence of iron deficiency, anaemia and Plasmodium infection (Figure 2). Mean haemoglobin concentrations were 113 g/L (SD 11.4 g/L) Screened (1,804) Excluded (1,334) • No show at randomisation (427) • Refused participation (286) • Not pregnant (227) • Homestead declined consent (210) • Medical reasons (39) • Carrying multiples (8) Randomised (470) Lost (37) • Emigrated from area (27) • Miscarried (4) • Non-compliant (4) • Unknown (2) Plasmodium infection status at delivery known (433) • All samples collected (424) • Venous bloodbut not placental samples collected (9) Figure 1. Participant flow Figure 2. Baseline characteristics of the study population Conclusions: Becausewehavebeensuccessful in implementingthe trial withfewwomenbeinglosttofollow-up, and capturing he vastmajority of placental and bloodsamples, weexpectthatthesefactorswillcreatelittlebias in trial results. Keywords: Iron, iron deficiency, anaemia, malaria, pregnancy, randomised controlled trial, Kenya This work was supported by the INSTAPA project, funded by the European Community’s Seventh Framework Programme (FP7/2007-2013) under grant agreement no. 211484. Poster Reference Number: PO1879
