Abstract / Summary
Introduction: Iron Deficiency Anaemia (IDA) is a major public health problem in children, particularly in low- and middle-income countries. Gastrointestinal intolerance and poor palatability of conventional oral iron often compromise adherence. Microencapsulated ferric saccharate (MFS) oral strips are a novel formulation designed to improve bioavailability and tolerability. Aim: To compare the effectiveness, tolerability, adverse effects and treatment compliance of MFS oral strips with Colloidal Elemental Iron (CEI) in children aged 4-18 years with IDA. Materials and Methods: This open-label randomised controlled trial was conducted at KLE Dr. Prabhakar Kore Hospital and Medical Research Centre, KAHER, Jawaharlal Nehru Medical College, Belagavi, Karnataka, India, from September 2024 to October 2025. A total of 60 children aged 4-18 years with IDA were randomised to receive either MFS oral strips or CEI for 12 weeks. Randomisation 1:1 by computer-generated sequence, allocation concealed in sequentially numbered opaque sealed envelopes. Laboratory staff assessing Haemoglobin (Hb) and ferritin were blinded. Deworming with albendazole 400 mg was given to both arms at enrollment before randomisation as per Indian Academy of Paediatrics (IAP) standard care. MFS dose: 27-54 mg/day fixed; CEI dose: 3-6 mg/kg/day (mean 68-139 mg/day based on mean weight 22.8-23.2 kg). Haemoglobin, red cell indices, iron profile, adverse effects and treatment compliance were assessed at baseline and after 12 weeks of therapy. Data were analysed using independent t-test, Chi-square test, Fisher’s exact test, Mann-Whitney U test and Wilcoxon signed-rank test. A p-value <0.05 was considered statistically significant. Results: Sixty children were enrolled, with 30 in each group (MFS=30; CEI=30). Baseline characteristics were comparable, including mean age (8.2±4.1 years vs 8.0±4.3 years) and haemoglobin levels (8.7±0.9 g/dL vs 8.6±0.9 g/dL). At three months, mean Hb rise was significantly higher in the experimental group than the control group (2.7±0.7 g/dL vs 2.0±0.8 g/dL; p-value <0.001). Gastrointestinal adverse effects occurred less frequently with the MFS group, and compliance was significantly better in the intervention group (p-value <0.001). Conclusion: In this small open-label trial, fixed-dose MFS strips showed greater Hb rise, lower GI events and higher adherence compared with weight-based CEI. This reflects combined effects of tolerability and adherence, not equivalent-dose bioavailability. Larger blinded trials with dose-equivalent comparison and cost-effectiveness are needed.