{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,27]],"date-time":"2026-07-27T10:58:54Z","timestamp":1785149934150,"version":"3.55.0"},"reference-count":30,"publisher":"MDPI AG","issue":"15","license":[{"start":{"date-parts":[[2026,7,27]],"date-time":"2026-07-27T00:00:00Z","timestamp":1785110400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Nemysis Ltd."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Nutrients"],"abstract":"<jats:p>Objective: To evaluate the real-world effectiveness and tolerability of Iron Hydroxide Adipate Tartrate (IHATTM) in women with iron deficiency across three common obstetric and gynecologic clinical settings: pregnancy, the postpartum period, and abnormal uterine bleeding. Methods: This prospective multicenter observational real-world study included women with iron deficiency managed in routine clinical practice across Italy. Participating gynecologists collected data using standardized case report forms. Patients received IHATTM according to routine clinical practice and were followed for approximately three months. Baseline demographic and hematologic parameters were recorded, including hemoglobin and ferritin levels. The primary outcome was the change in hemoglobin between baseline and follow-up. Secondary outcomes included changes in ferritin levels, treatment adherence, and tolerability. Results: A total of 517 women was included in the analysis. The study population included pregnant women (N = 287, 55.5%), women with abnormal uterine bleeding (N = 161, 31.1%), and women in the postpartum period (N = 69, 13.3%). Improvements in hemoglobin were observed across all clinical settings, with hemoglobin increasing from 10.35 g\/dL at baseline to 11.63 g\/dL at three months, corresponding to a mean increase of 1.28 g\/dL. Mean ferritin levels increased from 22.50 ng\/mL to 37.74 ng\/mL in three months. Treatment adherence was high or moderate in 93.4% of patients. Gastrointestinal adverse events were infrequent, with constipation (9.7%) and nausea (4.8%) among the most reported. Conclusions: In this prospective real-world multicenter study, treatment with IHATTM was associated with meaningful improvements in hemoglobin and iron stores in women with iron deficiency across pregnancy, postpartum, and abnormal uterine bleeding. The treatment showed good adherence and a favorable tolerability profile in routine clinical practice.<\/jats:p>","DOI":"10.3390\/nu18152446","type":"journal-article","created":{"date-parts":[[2026,7,27]],"date-time":"2026-07-27T09:47:41Z","timestamp":1785145661000},"page":"2446","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Real-World Effectiveness of IHATTM in Women with Iron Deficiency Across Pregnancy, Postpartum and Abnormal Uterine Bleeding"],"prefix":"10.3390","volume":"18","author":[{"given":"Gabriele","family":"Saccone","sequence":"first","affiliation":[{"name":"Department of Neuroscience, Reproductive Science and Dentistry, School of Medicine, University of Naples Federico II, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-0812-6716","authenticated-orcid":false,"given":"Mariarosaria","family":"Motta","sequence":"additional","affiliation":[{"name":"Department of Neuroscience, Reproductive Science and Dentistry, School of Medicine, University of Naples Federico II, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1611-0813","authenticated-orcid":false,"given":"Francesco","family":"De Seta","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, IRCCS San Raffaele Scientific Institute, University Vita and Salute, 20132 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-8313-1143","authenticated-orcid":false,"given":"Salvatore","family":"Mola","sequence":"additional","affiliation":[{"name":"Department of Neuroscience, Reproductive Science and Dentistry, School of Medicine, University of Naples Federico II, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-2733-0805","authenticated-orcid":false,"given":"Sara","family":"Iannantuoni","sequence":"additional","affiliation":[{"name":"Department of Neuroscience, Reproductive Science and Dentistry, School of Medicine, University of Naples Federico II, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1273-3335","authenticated-orcid":false,"given":"Nicoletta","family":"Di Simone","sequence":"additional","affiliation":[{"name":"Department of Biomedical Sciences, Humanitas University, 20072 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,7,27]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"676S","DOI":"10.1093\/jn\/131.2.676S","article-title":"Iron deficiency and reduced work capacity: A critical review","volume":"131","author":"Haas","year":"2001","journal-title":"J. Nutr."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"4","DOI":"10.1186\/1475-2891-9-4","article-title":"The effects of oral iron supplementation on cognition in older children and adults: A systematic review","volume":"9","author":"Falkingham","year":"2010","journal-title":"Nutr. J."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"2534","DOI":"10.1093\/jn\/138.12.2534","article-title":"Why iron deficiency is important in infant development","volume":"138","author":"Beard","year":"2008","journal-title":"J. Nutr."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"444","DOI":"10.1017\/S1368980008002401","article-title":"Worldwide prevalence of anemia","volume":"12","author":"McLean","year":"2009","journal-title":"Public Health Nutr."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"e16","DOI":"10.1016\/S2214-109X(13)70001-9","article-title":"Global, regional, and national trends in haemoglobin concentration and prevalence of total and severe anaemia in children and pregnant and non-pregnant women for 1995\u20132011: A systematic analysis of population-representative data","volume":"1","author":"Stevens","year":"2013","journal-title":"Lancet Glob. Health"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"e2413967","DOI":"10.1001\/jamanetworkopen.2024.13967","article-title":"Prevalence of Iron Deficiency Using 3 Definitions Among Women in the US and Canada","volume":"7","author":"Barton","year":"2024","journal-title":"JAMA Netw. Open"},{"key":"ref_7","first-page":"625","article-title":"Iron deficiency in women: Assessment, causes and consequences","volume":"14","author":"Coad","year":"2011","journal-title":"Curr. Opin. Clin. Nutr. Metab. Care"},{"key":"ref_8","doi-asserted-by":"crossref","unstructured":"Tolkien, Z., Stecher, L., Mander, A.P., Pereira, D.I.A., and Powell, J.J. (2015). Ferrous sulfate supplementation causes significant gastrointestinal side-effects in adults: A systematic review and meta-analysis. PLoS ONE, 10.","DOI":"10.1371\/journal.pone.0117383"},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"291","DOI":"10.1185\/03007995.2012.761599","article-title":"Tolerability of different oral iron supplements","volume":"29","author":"Palacios","year":"2013","journal-title":"Curr. Med. Res. Opin."},{"key":"ref_10","first-page":"2790","article-title":"Oral iron supplementation: New formulations, old questions","volume":"109","author":"Pantopoulos","year":"2024","journal-title":"Haematologica"},{"key":"ref_11","doi-asserted-by":"crossref","unstructured":"Tan, X., Tian, Y., Zhang, T., Yao, Q., Zhu, T., Wang, W., Wang, Q., and Fu, H. (2026). Oral iron preparations: Gastrointestinal adverse events and medication adherence in female patients with iron deficiency anemia. Front. Pharmacol., 17.","DOI":"10.3389\/fphar.2026.1727566"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"714","DOI":"10.1093\/jn\/nxab363","article-title":"A Novel Ferritin-Core Analog Is a Safe and Effective Alternative to Oral Ferrous Iron for Treating Iron Deficiency during Pregnancy in Mice","volume":"152","author":"Helman","year":"2022","journal-title":"J. Nutr."},{"key":"#cr-split#-ref_13.1","unstructured":"EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) (2021). Safety of iron hydroxide adipate tartrate as a novel food pursuant to regulation"},{"key":"#cr-split#-ref_13.2","unstructured":"(EU) 2015\/2283 and as a source of iron in the context of directive 2002\/46\/EC. EFSA J., 19, 6935."},{"key":"ref_14","doi-asserted-by":"crossref","unstructured":"Pereira, D.I., Mergler, B.I., Faria, N., Bruggraber, S.F., Aslam, M.F., Poots, L.K., Prassmayer, L., L\u00f6nnerdal, B., Brown, A.P., and Powell, J.J. (2013). Caco-2 cell acquisition of dietary iron(III) invokes a nanoparticulate endocytic pathway. PLoS ONE, 8, Erratum in PLoS ONE 2015, 10, e0119747. https:\/\/doi.org\/10.1371\/journal.pone.0119747.","DOI":"10.1371\/journal.pone.0119747"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"1877","DOI":"10.1016\/j.nano.2014.06.012","article-title":"Nanoparticulate iron (III) oxo-hydroxide delivers safe iron that is well absorbed and utilised in humans","volume":"10","author":"Pereira","year":"2014","journal-title":"Nanomedicine"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"1529","DOI":"10.1016\/j.nano.2013.12.011","article-title":"A nano-disperse ferritin-core mimetic that efficiently corrects anemia without luminal iron redox activity","volume":"10","author":"Powell","year":"2014","journal-title":"Nanomedicine"},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"1183","DOI":"10.1016\/j.bbamcr.2017.03.007","article-title":"Disruption of the epithelial barrier during intestinal inflammation: Quest for new molecules and mechanisms","volume":"1864","author":"Lechuga","year":"2017","journal-title":"Biochim. Biophys. Acta Mol. Cell Res."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"G397","DOI":"10.1152\/ajpgi.00348.2013","article-title":"Mechanistic and regulatory aspects of intestinal iron absorption","volume":"307","author":"Gulec","year":"2014","journal-title":"Am. J. Physiol. Gastrointest. Liver Physiol."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"101853","DOI":"10.1016\/j.eclinm.2023.101853","article-title":"A novel nano-iron supplement versus standard treatment for iron deficiency anaemia in children 6\u201335 months (IHAT-GUT trial): A double-blind, randomised, placebo-controlled non-inferiority phase II trial in The Gambia","volume":"56","author":"Mohammed","year":"2023","journal-title":"eClinicalMedicine"},{"key":"ref_20","doi-asserted-by":"crossref","unstructured":"\u00d6zbilen, M., and Kaya, Y. (2025). Beyond anemia: A comprehensive analysis of iron deficiency symptoms in women and their correlation with biomarkers. BMC Women\u2019s Health, 25.","DOI":"10.1186\/s12905-025-03906-w"},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"1232","DOI":"10.3324\/haematol.2019.220830","article-title":"Iron absorption from supplements is greater with alternate day than with consecutive day dosing in iron-deficient anemic women","volume":"105","author":"Stoffel","year":"2020","journal-title":"Haematologica"},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"1981","DOI":"10.1182\/blood-2015-05-642223","article-title":"Oral iron supplements increase hepcidin","volume":"126","author":"Moretti","year":"2015","journal-title":"Blood"},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"233","DOI":"10.1016\/S0140-6736(20)32594-0","article-title":"Iron deficiency","volume":"397","author":"Pasricha","year":"2021","journal-title":"Lancet"},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"153","DOI":"10.1111\/joim.13004","article-title":"Iron deficiency anaemia revisited","volume":"287","author":"Cappellini","year":"2020","journal-title":"J. Intern. Med."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"E680","DOI":"10.1503\/cmaj.240570","article-title":"Diagnosis and management of iron deficiency in females","volume":"197","author":"Sholzberg","year":"2025","journal-title":"CMAJ"},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"138","DOI":"10.14740\/gr804w","article-title":"Iron Pill Gastritis: An Under Diagnosed Condition with Potentially Serious Outcomes","volume":"10","author":"Sunkara","year":"2017","journal-title":"Gastroenterol. Res."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"339","DOI":"10.1053\/j.seminhematol.2015.07.003","article-title":"Iron deficiency anemia in pregnancy","volume":"52","author":"Breymann","year":"2015","journal-title":"Semin. Hematol."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"588","DOI":"10.1111\/j.1365-2141.2011.09012.x","article-title":"UK guidelines on iron deficiency in pregnancy","volume":"156","author":"Pavord","year":"2012","journal-title":"Br. J. Haematol."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"1247","DOI":"10.1007\/s00277-011-1279-z","article-title":"Postpartum anemia I: Definition, prevalence","volume":"90","author":"Milman","year":"2011","journal-title":"Ann. Hematol."}],"container-title":["Nutrients"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2072-6643\/18\/15\/2446\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,27]],"date-time":"2026-07-27T10:00:27Z","timestamp":1785146427000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2072-6643\/18\/15\/2446"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,27]]},"references-count":30,"journal-issue":{"issue":"15","published-online":{"date-parts":[[2026,8]]}},"alternative-id":["nu18152446"],"URL":"https:\/\/doi.org\/10.3390\/nu18152446","relation":{},"ISSN":["2072-6643"],"issn-type":[{"value":"2072-6643","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7,27]]}}}