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微粉化、微囊化富马酸亚铁以>您的<铁糖浆形式补充可改善缺铁儿童的血红蛋白和铁蛋白水平:疗效和安全性的双盲、随机临床研究。

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.

机构信息

Department of Pediatric Hematology and Oncology, University Children's Hospital, University Medical Centre Ljubljana, Bohoričeva ulica 20, 1000 Ljubljana, Slovenia.

The Chair of Clinical Biochemistry, Faculty of Pharmacy, University of Ljubljana, Aškerčeva cesta 7, 1000 Ljubljana, Slovenia.

出版信息

Nutrients. 2021 Mar 26;13(4):1087. doi: 10.3390/nu13041087.

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 ( = 0.04 and = 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.

摘要

口服铁补充剂在儿童中的疗效主要存在耐受性和依从性问题。本研究旨在确定新型食品补充剂>Your< Iron Syrup 补充铁储存和改善 9 个月至 6 岁缺铁儿童血液学参数的安全性和有效性。我们将 94 名缺铁健康儿童按 3:1 的比例随机分为接受>Your< Iron Syrup 或安慰剂治疗。与安慰剂相比,>Your< Iron Syrup 补充 12 周后铁蛋白和血红蛋白水平显著升高(=0.04 和=0.02)。两组不良反应报告频率相似。>Your< Iron Syrup 是一种有效、耐受性好且安全的治疗儿童营养性缺铁的选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/258f/8066233/9bb3c99dad6e/nutrients-13-01087-g001.jpg

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