A Study to compare the efficacy of conventional iron and Liposomal iron in treatment of iron defieciency anemia

Introduction

Iron deficiency anemia (IDA) is the most common nutritional anemia worldwide and remains a major public health concern among children and adolescents, particularly in developing countries like India. Factors such as rapid growth, inadequate dietary intake, recurrent infections, parasitic infestations, and low socioeconomic status contribute significantly to its high prevalence. IDA during childhood is associated with impaired cognitive development, reduced immunity, poor growth, and decreased scholastic performance, making early diagnosis and effective treatment essential.

Need for the Study

Oral iron supplementation is the cornerstone of treatment for nutritional IDA. Conventional iron preparations such as ferrous salts are commonly used but are often associated with gastrointestinal side effects, poor palatability, and reduced compliance, leading to inadequate therapeutic response. Liposomal iron, a newer formulation, offers improved bioavailability and better gastrointestinal tolerability due to its unique absorption through intestinal M cells and lymphatic transport. However, evidence comparing its efficacy and safety with conventional iron in the pediatric population is limited, particularly in the Indian setting.

Knowledge Gaps

There is a paucity of well-designed prospective studies comparing liposomal iron with conventional iron in children. Data regarding hematological response, adverse effect profile, and treatment adherence with liposomal iron in pediatric iron deficiency anemia remain insufficient, necessitating further research.

Aim and Objectives

The aim of this study is to compare the efficacy of conventional iron and liposomal iron in the treatment of iron deficiency anemia in children.

The primary objective is to compare the rise in hemoglobin concentration after 12 weeks of therapy between the two groups.

The secondary objectives include comparison of changes in MCV, corrected reticulocyte count, serum iron, serum ferritin, TIBC, transferrin saturation, adverse drug reactions, and treatment adherence.

Materials and Methods

This is a prospective comparative study conducted in the Department of Pediatrics, at a medical College in Barabanki district of central Uttar Pardesh. Children aged 6 months to 18 years diagnosed with nutritional iron deficiency anemia will be enrolled. A total of 80 participants will then randomized into two groups: one receiving conventional iron (ferrous ascorbate) and the other receiving liposomal iron. Patients are followed for 12 weeks, and clinical response, hematological parameters, adverse effects, and compliance are assessed and compared between the two groups.

Review of Literature

Previous studies have demonstrated that conventional iron preparations effectively increase hemoglobin levels but are frequently associated with gastrointestinal side effects. Emerging evidence suggests that liposomal iron provides comparable efficacy with improved tolerability and better patient compliance. However, limited pediatric data highlight the need for further comparative studies to establish its role in routine clinical practice

References

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3 Mantadakis E Chatzimichael E Zikidou P Iron deficiency anemia in children residing in high and low income countries risk factors prevention diagnosis and therapy Mediterranean Journal of Hematology and Infectious Diseases 2020 12 1

4 Patil P Geevarghese P Khaire P et al Comparison of therapeutic efficacy of ferrous ascorbate and iron polymaltose complex in iron deficiency anemia in children A randomized controlled trial Indian Journal of Pediatrics 2019 86 1112 to 1117

5 Russo G Guardabasso V Romano F et al Monitoring oral iron therapy in children with iron deficiency anemia An observational prospective multicenter study Annals of Hematology 2020 99 3 413 to 420

6 Pisani A Riccio E Sabbatini M et al Effect of oral liposomal iron versus intravenous iron for treatment of iron deficiency anemia A randomized trial Nephrology Dialysis Transplantation 2015 30 4 645 to 652