{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,16]],"date-time":"2026-04-16T15:32:21Z","timestamp":1776353541510,"version":"3.51.2"},"update-to":[{"DOI":"10.12688\/gatesopenres.13039.1","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2021,2,9]],"date-time":"2021-02-09T00:00:00Z","timestamp":1612828800000}}],"reference-count":56,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2021,2,9]],"date-time":"2021-02-09T00:00:00Z","timestamp":1612828800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000024","name":"Canadian Institutes of Health Research","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000024","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000865","name":"Bill and Melinda Gates Foundation","doi-asserted-by":"publisher","award":["OPP1139998"],"award-info":[{"award-number":["OPP1139998"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["gatesopenresearch.org"],"crossmark-restriction":false},"short-container-title":["Gates Open Res"],"abstract":"<ns4:p>\n                    The forms of iron currently available to correct iron deficiency have adverse effects, including infectious diarrhea, increased susceptibility to malaria, inflammation and detrimental changes to the gut microbiome. These adverse effects limit their use such that the growing burden of iron deficiency has not abated in recent decades. Here, we summarize the protocol of the \u201cSafe Iron Study\u201d, the first clinical study examining the safety and efficacy of novel forms of iron in healthy, iron-replete adults. The Safe Iron Study is a double-blind, randomized, placebo-controlled trial conducted in Boston, MA, USA. This study compares ferrous sulfate heptahydrate (FeSO\n                    <ns4:sub>4<\/ns4:sub>\n                    \u00b7H\n                    <ns4:sub>2<\/ns4:sub>\n                    O) with two novel forms of iron supplements (iron hydroxide adipate tartrate (IHAT) and organic fungal iron metabolite (Aspiron\u2122 Natural Koji Iron)). In Phase I, we will compare each source of iron administrated at a low dose (60 mg Fe\/day). We will also determine the effect of FeSO\n                    <ns4:sub>4<\/ns4:sub>\n                    co-administrated with a multiple micronutrient powder and weekly administration of FeSO\n                    <ns4:sub>4<\/ns4:sub>\n                    . The forms of iron found to produce no adverse effects, or adverse effects no greater than FeSO\n                    <ns4:sub>4<\/ns4:sub>\n                    in Phase I, Phase II will evaluate a higher, i.e., a therapeutic dose (120 mg Fe\/day). The primary outcomes of this study include\n                    <ns4:italic>ex vivo<\/ns4:italic>\n                    malaria (\n                    <ns4:italic>Plasmodium falciparum<\/ns4:italic>\n                    ) infectivity of host erythrocytes,\n                    <ns4:italic>ex vivo<\/ns4:italic>\n                    bacterial proliferation (of selected species) in presence of host plasma and intestinal inflammation assessed by fecal calprotectin. This study will test the hypotheses that the novel forms of iron, administered at equivalent doses to FeSO\n                    <ns4:sub>4<\/ns4:sub>\n                    , will produce similar increases in iron status in iron-replete subjects, yet lower increases in\n                    <ns4:italic>ex vivo<\/ns4:italic>\n                    malaria infectivity,\n                    <ns4:italic>ex vivo<\/ns4:italic>\n                    bacterial proliferation, gut inflammation. Ultimately, this study seeks to contribute to development of safe and effective forms of supplemental iron to address the global burden of iron deficiency and anemia.\n                  <\/ns4:p>\n                  <ns4:p>\n                    <ns4:bold>Registration:<\/ns4:bold>\n                    ClinicalTrials.gov identifier:\n                    <ns4:ext-link xmlns:ns5=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" ns5:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03212677\">NCT03212677<\/ns4:ext-link>\n                    ; registered: 11 July 2017.\n                  <\/ns4:p>","DOI":"10.12688\/gatesopenres.13039.2","type":"journal-article","created":{"date-parts":[[2021,2,9]],"date-time":"2021-02-09T10:37:03Z","timestamp":1612867023000},"page":"1510","update-policy":"https:\/\/doi.org\/10.12688\/gatesopenres.crossmark-policy","source":"Crossref","is-referenced-by-count":2,"title":["Safe and effective delivery of supplemental iron to healthy older adults: The double-blind, randomized, placebo-controlled trial protocol of the Safe Iron Study"],"prefix":"10.12688","volume":"3","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1760-3073","authenticated-orcid":false,"given":"Erin D.","family":"Lewis","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dayong","family":"Wu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0307-9378","authenticated-orcid":false,"given":"Joel B.","family":"Mason","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Athar H.","family":"Chishti","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John M.","family":"Leong","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kathryn","family":"Barger","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Simin N.","family":"Meydani","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gerald F.","family":"Combs","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2560","published-online":{"date-parts":[[2021,2,9]]},"reference":[{"key":"ref-1","doi-asserted-by":"publisher","first-page":"1461S-1467S","DOI":"10.3945\/ajcn.2010.28674F","article-title":"Iron bioavailability and dietary reference values.","volume":"91","author":"R Hurrell","year":"2010","journal-title":"Am J Clin Nutr."},{"key":"ref-2","doi-asserted-by":"publisher","first-page":"29-40","DOI":"10.1016\/S0140-6736(13)60437-7","article-title":"Effect of provision of daily zinc 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status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.21956\/gatesopenres.14152.r28311, Richard Hurrell, Laboratory of Human Nutrition, Institute of Food, Nutrition and Health, ETH Zurich (Swiss Federal Institute of Technology), Zurich, Switzerland, 09 Dec 2019, version 1, 3 approved with reservations","URL":"https:\/\/gatesopenresearch.org\/articles\/3-1510\/v1#referee-response-28311","order":0,"name":"referee-response-28311","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/gatesopenres.14450.r30389, Nana Gletsu-Miller, Department of Applied Health Science, School of Public Health, Indiana University Bloomington, Bloomington, IN, USA, 17 Feb 2021, version 2, indexed","URL":"https:\/\/gatesopenresearch.org\/articles\/3-1510\/v2#referee-response-30389","order":1,"name":"referee-response-30389","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/gatesopenres.14152.r29204, Sukru Gulec, Molecular Nutrition and Human Physiology Laboratory, Food Engineering Department, \u0130zmir Institute of Technology, \u0130zmir, Turkey, 03 Sep 2020, version 1, 3 approved with reservations","URL":"https:\/\/gatesopenresearch.org\/articles\/3-1510\/v1#referee-response-29204","order":2,"name":"referee-response-29204","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"This study is supported by the Bill & Melinda Gates Foundation [OPP1139998]. \n\nEDL is supported by a Canadian Institutes of Health Research Postdoctoral Fellowship. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":3,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}