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Daily versus twice daily dose of ferrous sulphate supplementation in pregnant women: A randomized clinical trial

Background: The International Nutritional Anaemia Consultative Group has recommended a twice daily dose of 65 mg elemental iron supplementation in pregnant women living in areas where anaemia is prevalent contrary to the World Health Organization (WHO) universal recommendation of a daily dose of 60 mg. Whether twice or daily dose schedules proffer a better outcome is a subject of on-going research. Objective: To compare the effectiveness of the once versus twice daily doses of ferrous sulphate in the prevention of iron deficiency anaemia in pregnancy. Methods: There are about one hundred and eighty two (182) pregnant women at gestational ages of 14-24 weeks with haemoglobin (Hb) levels ≥10 g/dl but ≤14.5 g/dl were recruited during the antenatal booking clinic. They were randomized into receiving either once daily dose (65 mg of elemental iron) or twice daily dose (130 mg of elemental iron) of ferrous sulphate. Pre and post- supplementation haemoglobin, serum iron and ferritin levels were assessed at recruitment and at 37 weeks gestation respectively. Results: Eighty-four (84) and 80 women respectively in the once and twice daily dose groups were analysed. The serum haemoglobin was significantly lower (P = 0.002) among those on once daily than those on twice daily supplementation. The side effects were however, significantly higher in the twice daily group (P = 0.005, P = 0.043 and P = 0.004 respectively). There were no differences between the serum ferritin levels pre and post supplementation in both groups just as they were no reported significant differences in both birth weight of neonates (P = 0.936) and average gestational age at delivery (P = 0.469) between the two groups. Conclusion: Once daily (65 mg elemental iron) ferrous sulphate is as effective as twice daily (130 mg elemental iron) dose regimen in prevention of Anaemia in pregnancy in a developing economy like Nigeria. Once daily dose possesses fewer side effects and guarantees better compliance in this study.