Liposomal Iron vs. Conventional Iron in the Treatment of Iron Deficiency Anemia in Children: A Randomized Controlled Trial.

INTRODUCTION

Despite their established efficacy, gastrointestinal adverse effects of ferrous iron lead to reduced acceptability, poor adherence to treatment, and the persistence of iron deficiency anemia (IDA). Liposomal iron is characterized by high bioavailability, reduced side effects, and improved compliance, making it appropriate for patients requiring iron supplementation. Hence, there is a need to compare conventional iron (ferrous ascorbate) with liposomal iron employed for the treatment of IDA in children.

AIMS AND

OBJECTIVES

The study aimed to compare the effectiveness and tolerability of liposomal iron with conventional elemental iron (ferrous ascorbate) in improving hemoglobin levels and iron indices among children aged 6-60 months with IDA.

METHODOLOGY: The study was conducted between June and September 2024 at SRM Medical College Hospital and Research Centre in Tamil Nadu, India. Children aged 6-60 months with confirmed IDA, not receiving any iron supplementation for three months prior to study inclusion, and with no other hematological disorders or active infections were included. A total of 98 children were included and allocated into two groups of 49 each. Group A was treated with liposomal iron (1 mg/kg/day), and Group B with ferrous ascorbate (3 mg/kg/day) for one month. The response to treatment in both groups was assessed. Statistical analysis was done using the chi-square test and the t-test.

RESULTS

Baseline characteristics were similar. The mean base hemoglobin in Group A was 8.4 g/dL, and that in Group B was 8.3 g/dL. After one month of iron supplementation, the mean hemoglobin only rose to 8.5 g/dL in Group A but to 9.3 g/dL in Group B. The difference in the rise of hemoglobin between Group A and Group B was significant (p=0.0018). Liposomal iron had adequate oral tolerance (p=0.042), better adherence (p=0.047), and a lesser incidence of constipation (p=0.046).

CONCLUSION

Despite poor oral tolerability, poor adherence, and a higher incidence of constipation, ferrous ascorbate was found to be superior compared to liposomal iron in treating children with IDA.