COMPARATIVE EFFICACY OF FERROUS SULPHATE MONOTHERAPY VERSUS COMBINATION THERAPY WITH VITAMIN C IN PEDIATRIC IRON DEFICIENCY ANEMIA: A RANDOMIZED CONTROLLED TRIAL

Abstract

Iron deficiency is the single most common cause of anaemia worldwide. Treatment consists of improved nutrition and oral, intramuscular, or intravenous iron administration. Objective: To compare the outcome of monotherapy with ferrous sulphate and combination therapy with ferrous sulphate and vitamin C in children with iron deficiency anaemia. Methods: This randomised controlled trial was conducted in the Department of Pediatric Medicine, The Children's Hospital and The Institute of Child Health (CH&ICH), Multan, over six months from January 20, 2022, to July 20, 2023. A total of 166 children with iron deficiency anaemia were included in the study. Participants were randomly assigned to two groups: Group A received ferrous sulphate 5 mg/kg/day Fe²⁺ orally on an empty stomach plus vitamin C 6.3 mg/kg/day, while Group B received ferrous sulphate without additional vitamin C. Baseline and post-treatment measurements of haemoglobin, serum ferritin, and mean corpuscular volume (MCV) were taken. Data were analysed using SPSS-20, applying descriptive statistics and Student’s t-test for comparison, with a significance level set at p≤0.05. Results: Of the 166 children, 111 (66.9%) were male, and 55 (33.1%) were female. The mean age was 24.55 ± 16.23 months. Rural residents accounted for 67 (40.4%), and urban residents were 99 (59.6%). Socioeconomically, 100 (60.2%) were from poor backgrounds, and 66 (39.8%) were middle-income. Among the mothers, 81 (48.8%) were illiterate, and 85 (51.2%) were literate. Post-treatment mean haemoglobin levels increased from 11.95 ± 1.02 g/dL to 12.74 ± 0.83 g/dL, serum ferritin levels from 30.73 ± 4.29 ng/mL to 32.87 ± 4.80 ng/mL, and MCV from 70.36 ± 3.81 fL to 74.49 ± 3.59 fL. Conclusion: Combination therapy with ferrous sulphate and vitamin C in pediatric patients with iron deficiency anaemia is well-tolerated and results in significant clinical improvement with minimal adverse reactions. This approach should be considered to enhance clinical outcomes, reduce morbidity, improve quality of life, and decrease healthcare costs.