Comparison of the efficacy and safety of succrosomial iron and elementar iron supplementation to treat iron deficiency and iron deficiency anemia in preschool children (3-6 years): protocol of a randomized clinical trial.

Abstract

Children are particularly vulnerable to iron deficiency and its consequences. The estimated prevalence of anemia in the world population is about 40%. According to WHO, 47% of preschool children and 25% of school-age children suffer from iron deficiency anemia.  Results of ongoing studies indicate that iron deficiency and anemia in children may impair their further development, both neurological and motor. The treatment of choice for iron deficiency and iron deficiency anemia is prolonged administration of oral iron preparations. Iron ions not absorbed from the intestine determine frequent adverse effects, which become a reason to abandon therapy with the prolongation of supplementation. Our study was designed to compare the efficacy of succrosomal and elemental iron supplementation in the treatment of iron deficiency and iron deficiency anemia in children aged 3-6 years by evaluating iron metabolism parameters. We also planned to assess the side effects of the studied supplements, the efficacy of the therapy with a single daily dose and the analysis of the occurrence and subsidence with the supplementation of clinical symptoms of iron deficiency or iron deficiency anemia in children aged 3-6 years. This is the single-center randomized comparative study. A total of 100 patients were planned to be enrolled in the study. Iron supplementation will be administered for 12 weeks. The primary aim of the study is to demonstrate that the effect of the application of succrosomal iron preparation is not worse than in the case of the application of elemental iron. The secondary objectives are to evaluate the adverse effects of the compared preparations, the efficacy of iron supplementation administered in a single daily dose and assess the occurrence and treatment-related resolution of iron deficiency symptoms and iron deficiency anemia in the study population.