Is liposomal iron superior in treating anemic children with congenital acyanotic heart diseases? A randomized controlled clinical trial

Abstract Background Children with congenital heart disease (CHD) often suffer from Iron deficiency anemia (IDA), which is linked to poorer clinical outcomes. Liposomal iron has been proposed as a promising advancement in iron supplementation across diverse populations. This study compared the efficacy as measured by changes in hemoglobin from baseline to end of study, and the tolerability of liposomal and conventional iron, with an emphasis on some clinical outcomes. Methods A randomized, double-blind, controlled clinical trial was conducted at Cairo University Children’s Hospital (CUCH). Sixty-seven children aged 6 months to 12 years with clinically stable children with hemodynamically insignificant acyanotic congenital heart disease (ACHD) and mild-to-moderate IDA were included. Patients were randomly assigned to one of the treatment regimens: oral iron hydroxide polymaltose complex (3 mg/kg/day) or oral liposomal iron (1 mg/kg/day) for four weeks. A nutritional assessment was performed, and hematological and iron indices were evaluated. Results After four weeks of iron supplementation, the percentage changes in Hb ( p = 0.137) and other hematological and iron indices did not differ between the two intervention groups, except for greater improvement in anemia severity grading in the liposomal iron group ( p = 0.05). A lower incidence of constipation ( p = 0.015) and metallic taste ( p = 0.007) was reported in the liposomal iron group. Conclusions No significant difference was observed between the two treatment groups in Hb levels and other hematological and iron indices after four weeks of treatment. However, fewer adverse effects were reported in the liposomal iron group. Registry PACTR, TRN: PACTR202501496307274, and date of registration: January 23, 2025.