Abstract
Background: Iron deficiency anemia (IDA) is the most prevalent nutritional deficiency among children worldwide, especially in developing countries. It adversely affects physical growth, cognitive development, and immune function. Children aged 6–36 months are particularly at risk due to increased iron demands and inadequate dietary intake. Oral iron therapy, primarily with ferrous salts, is the standard treatment. However, the comparative efficacy and tolerability of different iron preparations require further investigation. Objective: To compare the efficacy and tolerability of ferrous sulfate (FS) and ferrous gluconate (FG) in treating iron deficiency anemia in children aged 6 to 36 months by evaluating changes in hemoglobin and serum ferritin levels after six weeks of treatment. Methods: This randomized controlled trial was conducted at The Institute of Child Health & The Children’s Hospital, Lahore. A total of 70 children aged 6 to 36 months with confirmed IDA (hemoglobin <10 g/dL, serum ferritin <10 ng/mL) were enrolled and randomized into two groups: Group A (n=35): Received oral ferrous sulfate [3 mg/kg elemental iron/day]. Group B (n=35): Received oral ferrous gluconate at an equivalent elemental iron dose. Treatment was administered daily for six weeks. Compliance and side effects were assessed weekly. Hemoglobin and serum ferritin levels were measured at baseline and after treatment. Paired and unpaired t-tests were used for intra- and inter- group comparisons, respectively. Results: Both groups showed a significant increase in hemoglobin and ferritin levels from baseline after six weeks of therapy (p<0.001). However, the ferrous gluconate group demonstrated a significantly greater improvement: Mean hemoglobin increase: FG: 2.8 ± 0.6 g/dL vs. FS: 2.2 ± 0.5 g/dL (p=0.002) Mean ferritin increase: FG: 24.5 ± 6.3 ng/mL vs. FS: 18.1 ± 5.7 ng/mL (p=0.001) Additionally, gastrointestinal side effects (e.g., nausea, constipation) were less frequent in the FG group compared to the FS group (11% vs. 26%). Conclusion: Ferrous gluconate was more effective and better tolerated than ferrous sulfate in treating iron deficiency anemia in young children. Given its superior efficacy and lower incidence of side effects, ferrous gluconate may be a preferred option in this age group. Larger multicenter studies are recommended to validate these findings and explore long-term outcomes.