Micronized, Microencapsulated Ferric Iron Supplementation in the Form of >Your< Iron Syrup Improves Hemoglobin and Ferritin Levels in Iron-Deficient Children: Double-Blind, Randomized Clinical Study of Efficacy and Safety.

Aida Zečkanović,Marko Kavčič,Tomaž Prelog,Alenka Šmid,Janez Jazbec

doi:10.3390/nu13041087

Aida Zečkanović, Marko Kavčič + Show 3 more

Open Access

https://doi.org/10.3390/nu13041087

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Abstract

A major problem of oral iron supplementation efficacy in children is its tolerability and compliance. We aimed to determine the safety and efficacy of a novel food supplement >Your< Iron Syrup in the replenishment of iron stores and improvement of hematological parameters in iron-deficient children aged nine months to six years. We randomized 94 healthy children with iron deficiency in a ratio of 3:1 to either receive >Your< Iron Syrup or placebo. A 12-week supplementation with >Your< Iron Syrup resulted in a significant increase in ferritin and hemoglobin levels as compared to placebo (p = 0.04 and p = 0.02). Adverse events were reported with similar frequencies across both study arms. >Your< Iron Syrup represents an effective, well-tolerated, and safe option for the management of nutritional iron deficiency in children.

Highlights

Arija ValIron is an essential micronutrient indispensable for numerous metabolic processes.Depletion of iron from body stores manifests as decreased levels of serum ferritin and is regarded as iron deficiency (ID)
A total of 141 children met eligibility criteria, and 94 were enrolled in the study (47 were not willing to participate in the study)
Of the 70 children who were randomized to >Your< Iron Syrup arm, 64 children (91%) completed the study, and 3 children were withdrawn prior to interim follow-up due to randomization mistake or due to an adverse events (AE). Another two children withdrew between interim and final follow-up

Summary

Introduction

Arija ValIron is an essential micronutrient indispensable for numerous metabolic processes.Depletion of iron from body stores manifests as decreased levels of serum ferritin and is regarded as iron deficiency (ID). Iron is an essential micronutrient indispensable for numerous metabolic processes. ID progresses to iron deficiency anemia (IDA) presenting with low hemoglobin concentration and microcytosis. At this stage, pallor, irritability, fatigue, lethargy, and pica become evident [1,2]. Since iron plays a role in essential neurologic processes such as neurotransmitter synthesis and myelination, ID, with or without anemia, is thought to impact cognitive, behavioral, and motor development. While correction of iron status has the potential to improve these outcomes, some impairment may be irreversible [3]. It is substantial to ensure adequate iron intake and manage ID when identified [4]

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