Micronized, Microencapsulated Ferric Iron Supplementation in the Form of >Your Aida Zečkanović  1 , Marko Kavčič  1 , Tomaž Prelog  1 , Alenka Šmid  2 , Janez Jazbec  1 Affiliations Expand Affiliations 1 Department of Pediatric Hematology and Oncology, University Children's Hospital, University Medical Centre Ljubljana, Bohoričeva ulica 20, 1000 Ljubljana, Slovenia. 2 The Chair of Clinical Biochemistry, Faculty of Pharmacy, University of Ljubljana, Aškerčeva cesta 7, 1000 Ljubljana, Slovenia. PMID: 33810451 PMCID: PMC8066233 DOI: 10.3390/nu13041087 Free PMC article Item in Clipboard

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

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.

Keywords: children; food supplement; iron deficiency; liquid; microencapsulated iron; pediatric; supplementation; syrup.

Conflict of interest statement

The authors declare no conflict of interest. PharmaLinea Ltd. is involved in the marketing and sales of >Your< Iron Syrup; therefore, it has a commercial interest in this publication. PharmaLinea Ltd. and all authors declare that the data in this publication is a true and faithful representation of the performed work.

Figures

Figure 1
Figure 1
Flow diagram of the participant’s progress through the study.

References

    1. Pasricha S.R., Hayes E., Kalumba K., Biggs B.A. Effect of daily iron supplementation on health in children aged 4-23 months: A systematic review and meta-analysis of randomised controlled trials. Lancet Glob. Health. 2013;1:e77–e86. doi: 10.1016/S2214-109X(13)70046-9.
    1. McDermid J.M., Lönnerdal B. Iron. Adv. Nutr. 2012;3:532–533. doi: 10.3945/an.112.002261.
    1. Georgieff M.K. Long-term brain and behavioral consequences of early iron deficiency. Nutr. Rev. 2011;69:43–48. doi: 10.1111/j.1753-4887.2011.00432.x.
    1. Domellöf M., Braegger C., Campoy C., Colomb V., Decsi T., Fewtrell M., Hojsak I., Mihatsch W., Molgaard C., Shamir R., et al. Iron requirements of infants and toddlers. J. Pediatric Gastroenterol. Nutr. 2014;58:119–129. doi: 10.1097/MPG.0000000000000206.
    1. Camaschella C. Iron-deficiency anemia. N. Engl. J. Med. 2015;372:1832–1843. doi: 10.1056/NEJMra1401038.
    1. WHO . Nutritional Anaemias: Tools for Effective Prevention and Control. World Health Organization; Geneva, Switherland: 2017. pp. 1–83.
    1. WHO . Guideline: Intermittent Iron Supplementation in Preschool and School-Age Children. World Health Organization; Geneva, Switherland: 2011. pp. 1–32.
    1. WHO . Guideline on Use of Ferritin Concentrations To Assess Iron Status in Individuals and Populations. World Health Organization; Geneva, Switherland: 2020. pp. 1–82.
    1. WHO . The Global Prevalence of Anaemia in 2011. World Health Organization; Geneva, Switherland: 2015. pp. 1–48.
    1. Clénin G.E. The treatment of iron deficiency without anaemia (in otherwise healthy persons) Swiss Med. Wkly. 2017;147:1–17. doi: 10.4414/smw.2017.14434.
    1. Thompson J., Biggs B.A., Pasricha S.R. Effects of daily iron supplementation in 2- to 5-year-old children: Systematic review and meta-analysis. Pediatrics. 2013;131:739–753. doi: 10.1542/peds.2012-2256.
    1. Ullrich C., Wu A., Armsby C., Rieber S., Wingerter S., Brugnara C., Deficiency R.O.N., The I.S., Com M. Using Reticulocyte Hemoglobin Content. Am. J. Hematol. 2005;294:924–930.
    1. Soppi E. Iron Deficiency Without Anemia–Common, Important, Neglected. Clin. Case Rep. Rev. 2019;5:1–7. doi: 10.15761/CCRR.1000456.
    1. Pachuta Węgier L., Kubiak M., Liebert A., Clavel T., Montagne A., Stennevin A., Roye S., Boudribila A. Ferrous sulfate oral solution in young children with iron deficiency anemia: An open-label trial of efficacy, safety, and acceptability. Pediatric Int. 2020;62:820–827. doi: 10.1111/ped.14237.
    1. Hawamdeh H.M., Rawashdeh M., Aughsteen A.A. Comparison between once weekly, twice weekly, and daily oral iron therapy in Jordanian children suffering from iron deficiency anemia. Matern. Child Health J. 2013;17:368–373. doi: 10.1007/s10995-012-0981-3.
    1. Faqih A.M., Kakish S.B., Izzat M. Effectiveness of intermittent iron treatment of two- to six-year-old Jordanian children with iron-deficiency anemia. Food Nutr. Bull. 2006;27:220–227. doi: 10.1177/156482650602700304.
    1. Arora S., Kapoor R.K. Iron metabolism in humans: An Overview. InTech. 2012;70:626–632.
    1. Choi H.S., Song S.H., Lee J.H., Kim H.J., Yang H.R. Serum hepcidin levels and iron parameters in children with iron deficiency. Korean J. Hematol. 2012;47:286–292. doi: 10.5045/kjh.2012.47.4.286.
    1. Suganya V., Anuradha V. Microencapsulation and Nanoencapsulation: A Review. Int. J. Pharm. Clin. Res. 2017;9:233–239. doi: 10.25258/ijpcr.v9i3.8324.
    1. Finlayson-Trick E.C., Fischer J.A., Goldfarb D.M., Karakochuk C.D. The Effects of Iron Supplementation and Fortification on the Gut Microbiota: A Review. Gastrointest. Disord. 2020;2:30. doi: 10.3390/gidisord2040030.
    1. Szymlek-Gay E.A., Ferguson E.L., Heath A.L.M., Gray A.R., Gibson R.S. Food-based strategies improve iron status in toddlers: A randomized controlled trial. Am. J. Clin. Nutr. 2009;90:1541–1551. doi: 10.3945/ajcn.2009.27588.
    1. Fidler M.C., Walczyk T., Davidsson L., Zeder C., Sakaguchi N., Juneja L.R., Hurrell R.F. A micronised, dispersible ferric pyrophosphate with high relative bioavailability in man. Br. J. Nutr. 2004;91:107–112. doi: 10.1079/BJN20041018.
    1. Waller A.W., Andrade J.E., Mejia L.A. Performance factors influencing efficacy and effectiveness of iron fortification programs of condiments for improving anemia prevalence and iron status in populations: A systematic review. Nutrients. 2020;12:275. doi: 10.3390/nu12020275.
    1. Blanco-Rojo R., Pérez-Granados A.M., Toxqui L., González-Vizcayno C., Delgado M.A., Vaquero M.P. Efficacy of a microencapsulated iron pyrophosphate-fortified fruit juice: A randomised, double-blind, placebo-controlled study in Spanish iron-deficient women. Br. J. Nutr. 2011;105:1652–1659. doi: 10.1017/S0007114510005490.
    1. Navas-Carretero S., Pérez-Granados A.M., Sarriá B., Vaquero M.P. Iron absorption from meat pate fortified with ferric pyrophosphate in iron-deficient women. Nutrition. 2009;25:20–24. doi: 10.1016/j.nut.2008.07.002.
    1. Moretti D., Zimmermann M.B., Muthayya S., Thankachan P., Lee T.C., Kurpad A.V., Hurrell R.F. Extruded rice fortified with micronized ground ferric pyrophosphate reduces iron deficiency in Indian schoolchildren: A double-blind randomized controlled trial1-3. Am. J. Clin. Nutr. 2006;84:822–829. doi: 10.1093/ajcn/84.4.822.
    1. Roe M.A., Collings R., Hoogewerff J., Fairweather-Tait S.J. Relative bioavailability of micronized, dispersible ferric pyrophosphate added to an apple juice drink. Eur. J. Nutr. 2009;48:115–119. doi: 10.1007/s00394-008-0770-3.
    1. Hussain U., Zia K., Iqbal R., Saeed M., Ashraf N. Efficacy of a Novel Food Supplement (Ferfer®) Containing Microencapsulated Iron in Liposomal Form in Female Iron Deficiency Anemia. Cureus. 2019;11:1–7. doi: 10.7759/cureus.4603.
    1. Ple A., Ple C., Rosoga N., Nedelcu S. Efficacy and tolerability of a novel food supplement (Turbofer®) containing microencapsulated iron in liposomal form, in female iron deficiency anemia. J. Nutr. Int. Med. 2015;17:214–219.
    1. Parisi F., Berti C., Mandò C., Martinelli A., Mazzali C., Cetin I. Effects of different regimens of iron prophylaxis on maternal iron status and pregnancy outcome: A randomized control trial. J. Matern. Neonatal Med. 2017;30:1787–1792. doi: 10.1080/14767058.2016.1224841.

Source: PubMed

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