Research Article

Comparison of the Efficacy and Safety of Carbonyl Iron and Ferrous Sulphate for the Treatment of Iron Deficiency Anaemia in Pregnancy: A Randomized Controlled Clinical Trial

Abstract

Background: Iron deficiency anaemia in pregnancy is a significant public health issue in low- and middle-income countries and is associated with considerable morbidity and mortality. The treatment for mild to moderate cases typically involves oral iron supplements. There are various iron formulations available, each with differing levels of effectiveness, tolerability and safety, which can impact compliance and treatment efficacy. Therefore, it is essential to evaluate the efficacy and tolerability of these drugs in the treatment of iron deficiency anaemia during pregnancy. Objective: This study was designed to compare the efficacy and safety of Carbonyl iron with ferrous sulphate for the treatment of iron deficiency anaemia in pregnancy among pregnant women attending the antenatal clinic of the Federal Teaching Hospital, Katsina. Methodology: This study was a prospective, single-blinded randomized clinical trial. One hundred and eighty (180) pregnant women between the gestational ages of 14-28 weeks with Hb<11 g/dl. were recruited during the antenatal booking clinic. They were randomized to receive either 200mg ferrous sulphate or 50mg carbonyl iron twice daily after informed consent has been obtained. Full blood count and malaria RDT were conducted at enrollment, with a repeat of the full blood count at 12 weeks post-therapy. Participants were then followed up till delivery. Data was analyzed using IBM SPSS version 25.0. Descriptive statistical analysis encompassing frequency, percentage, mean, and standard deviations were used to depict results. Prevalence of anaemia in pregnancy was calculated as a percentage of all women with Hb<11 g/dl. A paired t-test was used to assess intra-group improvements, while an unpaired t-test and bivariate analysis were used to evaluate inter-group improvement in haemoglobin concentration, MCV, MCH, and MCHC. A p-value of ≤ 0.05 was used to indicate statistical significance. Results: The prevalence of anaemia among participants was 58.2%, with 16.4% classified as mild and 83.6% as moderate anaemia. Both treatments significantly improved haemoglobin levels, with Carbonyl Iron showing a greater increase compared to Ferrous Sulphate (p = 0.036) Carbonyl Iron was associated with fewer gastrointestinal side effects, indicating better tolerability (p = 0.016 for vomiting). Maternal and neonatal outcomes, including gestational age at delivery, Apgar scores, and birth weight, were comparable between the two groups. Conclusion: Carbonyl Iron is more effective and better tolerated than Ferrous Sulphate for managing iron deficiency anaemia in pregnancy. The findings support its use as a preferred treatment option, with implications for improving health outcomes in pregnant women.