OBJECTIVE: This study aimed to investigate the therapeutic effect of iron supplementation combined with anti-Helicobacter pylori(H.Pylori) therapy on patients with iron-deficiency anemia with concomitant H.Pylori infection. METHODS: Sixty-eight out of 143 children with iron-deficiency anemia were confirmed to have concomitant H. Pylori infection by the 13C-urea breath test. The 68 patients were randomly assigned into two groups: Study group (n=35) and Control group (n=33). The Control group received oral ferrous sulfate, with a dosage of 2 mg/kg for three times daily. Iron supplementation together with anti-H.Pylori therapy (losec 0.8 mg/kg, amoxicillin 50 mg/kg and clazithromycin 15 mg/kg daily for two weeks) was administered in the Study group. The therapeutic effect was compared between the two groups. RESULTS: At the 8th week after treatment, the levels of hemoglobin, serum iron and serum ferritin in the two groups significantly increased. The Study group showed significantly higher levels of hemoglobin, serum iron and serum ferritin than the Control group. CONCLUSIONS: H.Pylori infection may be associated with iron-deficiency anemia. Iron supplementation together with anti-H.Pylori therapy is more effective than iron supplementation therapy alone on children with iron-deficiency anemia with concomitant H.Pylori infection.