{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T02:49:57Z","timestamp":1784170197415,"version":"3.55.0"},"reference-count":41,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2021,6,15]],"date-time":"2021-06-15T00:00:00Z","timestamp":1623715200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JPGN rep."],"published-print":{"date-parts":[[2021,8]]},"abstract":"<jats:sec><jats:title>Objectives:<\/jats:title><jats:p>Iron deficiency is common in children and can have negative effects on behavior and function. Standard oral ferrous iron replacement is poorly absorbed and can cause treatment\u2010limiting gastrointestinal adverse events (AEs). Ferric maltol is formulated to improve gastrointestinal absorption and tolerability versus oral ferrous compounds. In adult phase 3 trials, it increased hemoglobin and iron stores versus placebo, with a gastrointestinal AE profile similar to placebo. Here, we assess different doses of ferric maltol in children with iron deficiency.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods:<\/jats:title><jats:p>This phase 1 trial involved children of age 10 to 17 years with ferritin &lt;30 \u00b5g\/L (or &lt;50 \u00b5g\/L with transferrin saturation [TSAT] &lt;20%). Children were randomized 1:1:1 to oral ferric maltol 7.8 mg, 16.6 mg, or 30 mg twice daily for 9 days and once on day 10. The primary outcomes were iron uptake measures (serum iron and TSAT) and population pharmacokinetic analyses.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results:<\/jats:title><jats:p>The trial included 37 children (mean age 14.0 years; baseline mean \u00b1 standard deviation ferritin 16.3 \u00b1 8.02 \u00b5g\/L). Ferric maltol increased iron uptake nondose\u2010proportionally: serum iron and TSAT plateaued between the 2 higher doses on day 1 and were comparable across all doses on day 10. Twenty children (54%) experienced AEs (all mild\/moderate, gastrointestinal 32%), with similar frequencies in each group.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions:<\/jats:title><jats:p>All 3 ferric maltol doses increased iron uptake in children with iron deficiency, even over the short study duration, and were well tolerated. Nondose\u2010dependent changes in serum iron and TSAT indicate physiologic regulation of iron uptake to meet the body's needs.<\/jats:p><\/jats:sec>","DOI":"10.1097\/pg9.0000000000000090","type":"journal-article","created":{"date-parts":[[2021,6,15]],"date-time":"2021-06-15T17:00:09Z","timestamp":1623776409000},"source":"Crossref","is-referenced-by-count":5,"title":["Safety, Tolerability, and Pharmacokinetics of Oral Ferric Maltol in Children With Iron Deficiency"],"prefix":"10.1002","volume":"2","author":[{"given":"Stephen","family":"Allen","sequence":"first","affiliation":[{"name":"Department of Clinical Sciences Liverpool School of Tropical Medicine Liverpool UK"},{"name":"Department of Paediatric Gastroenterology, Hepatology and Nutrition Alder Hey Children's NHS Foundation Trust Liverpool UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcus Karl\u2010Heinz","family":"Auth","sequence":"additional","affiliation":[{"name":"Department of Paediatric Gastroenterology, Hepatology and Nutrition Alder Hey Children's NHS Foundation Trust Liverpool UK"},{"name":"Faculty of Health and Life Sciences University of Liverpool Liverpool UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jon Jin","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Paediatric Nephrology Nottingham Children's Hospital Nottingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Babu","family":"Vadamalayan","sequence":"additional","affiliation":[{"name":"Paediatric Gastroenterology and Nutrition Service King's College Hospital NHS Foundation Trust London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,6,15]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.21037\/tp.2019.01.01"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.2147\/NDT.S72491"},{"key":"e_1_2_7_4_1","first-page":"629","article-title":"What is appropriate management of iron deficiency for young children?","volume":"55","author":"Bhargava S","year":"2006","journal-title":"J Fam Pract"},{"key":"e_1_2_7_5_1","first-page":"197","article-title":"Long lasting effects of infancy iron deficiency \u2013 preliminary results","volume":"71","author":"Yehuda S","year":"2006","journal-title":"J Neural Transm Suppl"},{"key":"e_1_2_7_6_1","first-page":"163","volume-title":"Comparative Quantification of Health Risks: Global and Regional Burden of Disease Attributable to Selected Major Risk Factors","author":"Stoltzfus RJ","year":"2004"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.107.6.1381"},{"key":"e_1_2_7_8_1","unstructured":"National Institute for Health and Care Excellence. Anaemia \u2013 iron deficiency.Clinical knowledge summary.2018. Available at:https:\/\/cks.nice.org.uk\/anaemia\u2010iron\u2010deficiency. Accessed June 1 2021."},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1136\/gut.2010.228874"},{"key":"e_1_2_7_10_1","unstructured":"British Columbia Guidelines and Protocols Advisory Committee.Iron deficiency \u2013 diagnosis and management. Effective date: April 17 2019. Available at:https:\/\/www2.gov.bc.ca\/assets\/gov\/health\/practitioner\u2010pro\/bc\u2010guidelines\/iron\u2010deficiency.pdf. Accessed June 1 2021."},{"key":"e_1_2_7_11_1","unstructured":"National Institute for Health and Care Excellence.BNF for Children. Available at:https:\/\/bnfc.nice.org.uk\/. Published 2021. Accessed June 1 2021."},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/ajh.24820"},{"key":"e_1_2_7_13_1","unstructured":"Accord\u2010UK Ltd.Ferrous Sulphate Tablets BP 200mg. Summary of product characteristics. Available at:https:\/\/www.medicines.org.uk\/emc\/product\/5930\/smpc. Accessed June 1 2021."},{"key":"e_1_2_7_14_1","unstructured":"ADVANZ Pharma. Ferrous Fumarate 210mg Tablets.Summary of product characteristics. Available at:https:\/\/www.medicines.org.uk\/emc\/product\/2821\/smpc. Accessed June 1 2021."},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2017.6846"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1097\/MD.0000000000007550"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2036.1998.00380.x"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1093\/ajcn\/69.2.250"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1136\/gut.2003.035758"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1097\/MIB.0000000000000314"},{"key":"e_1_2_7_21_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.13665"},{"key":"e_1_2_7_22_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2014-307720"},{"key":"e_1_2_7_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jnutbio.2019.01.010"},{"key":"e_1_2_7_24_1","doi-asserted-by":"publisher","DOI":"10.1681\/ASN.2006080856"},{"key":"e_1_2_7_25_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10620-009-1108-6"},{"key":"e_1_2_7_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjmed.2008.07.012"},{"key":"e_1_2_7_27_1","doi-asserted-by":"publisher","DOI":"10.4291\/wjgp.v6.i3.62"},{"key":"e_1_2_7_28_1","doi-asserted-by":"publisher","DOI":"10.1097\/ACO.0000000000000181"},{"key":"e_1_2_7_29_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2257.1989.tb00222.x"},{"key":"e_1_2_7_30_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2710.1991.tb00292.x"},{"key":"e_1_2_7_31_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.2042-7158.1987.tb06249.x"},{"key":"e_1_2_7_32_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1476-5381.1991.tb12240.x"},{"key":"e_1_2_7_33_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1476-5381.1991.tb12187.x"},{"key":"e_1_2_7_34_1","unstructured":"Norgine Limited. Feraccru 30mg hard capsules.Summary of product characteristics. Available at:https:\/\/www.medicines.org.uk\/emc\/product\/2083\/smpc. Accessed June 1 2021."},{"key":"e_1_2_7_35_1","first-page":"123","article-title":"Toxicological evaluation of certain food additives \u2013 International Programme on Chemical Safety IPCS","volume":"16","author":"World Health Organization","year":"1980","journal-title":"FAO Nutr Meet Rep Ser"},{"key":"e_1_2_7_36_1","doi-asserted-by":"crossref","unstructured":"PergolaPE KopytNP. Oral ferric maltol for the treatment of iron\u2010deficiency anemia in patients with CKD: a randomized trial and open\u2010label extension.Am J Kidney Dis.; Published online May 21 2021. doi:","DOI":"10.1053\/j.ajkd.2021.03.020"},{"key":"e_1_2_7_37_1","unstructured":"European Medicines Agency Science Medicines Health Committee for Medicinal Products for Human Use.EMA\/172417\/2018 assessment report: Feraccru.2018. Available at:https:\/\/www.ema.europa.eu\/en\/documents\/variation\u2010report\/feraccru\u2010h\u2010c\u20102733\u2010ii\u20100010\u2010epar\u2010assessment\u2010report\u2010variation_en.pdf. Accessed June 1 2021."},{"key":"e_1_2_7_38_1","doi-asserted-by":"publisher","DOI":"10.1185\/03007995.2012.761599"},{"key":"e_1_2_7_39_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0117383"},{"key":"e_1_2_7_40_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12185-017-2373-3"},{"key":"e_1_2_7_41_1","doi-asserted-by":"publisher","DOI":"10.1016\/0006-2952(88)90556-4"},{"issue":"2","key":"e_1_2_7_42_1","article-title":"Ferric maltol, unlike ferrous sulphate, does not adversely affect the intestinal microbiome","volume":"68","author":"Mahalhal A","year":"2019","journal-title":"Gut"}],"container-title":["JPGN Reports"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1097\/PG9.0000000000000090","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,6,12]],"date-time":"2025-06-12T14:33:42Z","timestamp":1749738822000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1097\/PG9.0000000000000090"}},"subtitle":["Phase 1 Study"],"short-title":[],"issued":{"date-parts":[[2021,6,15]]},"references-count":41,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2021,8]]}},"alternative-id":["10.1097\/PG9.0000000000000090"],"URL":"https:\/\/doi.org\/10.1097\/pg9.0000000000000090","archive":["Portico"],"relation":{},"ISSN":["2691-171X","2691-171X"],"issn-type":[{"value":"2691-171X","type":"print"},{"value":"2691-171X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,6,15]]},"article-number":"e090"}}