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In most high-income countries where IDA prevalence is &lt;\u200915%, the recommended daily intake levels of iron from supplements and\/or consumption of fortified food products are at odds with World Health Organisation (WHO) guidelines that recommend shorter-term (3\u00a0months\/year) supplementation only in populations with IDA prevalence &gt;\u200940%. Emerging concerns about delayed neurological effects of early-life iron overexposure have raised questions as to whether recommended guidelines in high-income countries are unnecessarily excessive. This systematic review will gather evidence from supplementation\/fortification trials, comparing health outcomes in studies where iron-replete children did or did not receive additional dietary iron; and determine if replete children at study outset were not receiving additional iron show changes in haematological indices of ID\/IDA over the trial duration.<\/jats:p>\n              <\/jats:sec>\n              <jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>We will perform a systematic review of the literature, including all studies of iron supplementation and\/or fortification, including study arms with confirmed iron-replete infants at the commencement of the trial. This includes both dietary iron intervention or placebo\/average dietary intakes. One reviewer will conduct searches in electronic databases of published and ongoing trials (Medline, Web of Science, Scopus, CENTRAL, EBSCO [e.g. CINAHL Complete, Food Science and Technology Abstracts], Embase, ClinicalTrials.gov, ClinicalTrialsRegister.eu and who.it\/trialsearch), digital theses and dissertations (WorldCat, Networked Digital Library of Theses and Dissertations, DART-Europe E-theses Portal, Australasian Digital Theses Program, Theses Canada Portal and ProQuest). For eligible studies, one reviewer will use a data extraction form, and a second reviewing entered data for accuracy. Both reviewers will independently perform quality assessments before qualitative and, if appropriate, quantitative synthesis as a meta-analysis. We will resolve any discrepancies through discussion or consult a third author to resolve discrepancies. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement will be used as the basis for reporting.<\/jats:p>\n              <\/jats:sec>\n              <jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>Recommended iron supplementation and food fortification practices in high-income countries have been criticised for being both excessive and based on outdated or underpowered studies. This systematic review will build a case for revisiting iron intake guidelines for infants through the design of new trials where health effects of additional iron intake in iron-replete infants are the primary outcome.<\/jats:p>\n              <\/jats:sec>\n              <jats:sec>\n                <jats:title>Systematic review registration<\/jats:title>\n                <jats:p>PROSPERO CRD42018093744.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13643-019-1185-3","type":"journal-article","created":{"date-parts":[[2019,11,1]],"date-time":"2019-11-01T10:14:32Z","timestamp":1572603272000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Health outcomes of iron supplementation and\/or food fortification in iron-replete children aged 4\u201324\u00a0months: protocol for a systematic review and meta-analysis"],"prefix":"10.1186","volume":"8","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5922-7643","authenticated-orcid":false,"given":"Dominic J.","family":"Hare","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sabine","family":"Braat","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"B\u00e1rbara R.","family":"Cardoso","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christopher","family":"Morgan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ewa A.","family":"Szymlek-Gay","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Beverley-Ann","family":"Biggs","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2019,11,1]]},"reference":[{"issue":"1","key":"1185_CR1","doi-asserted-by":"publisher","first-page":"54","DOI":"10.1016\/j.siny.2006.10.007","volume":"12","author":"R Rao","year":"2007","unstructured":"Rao R, Georgieff MK. 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