{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,20]],"date-time":"2026-09-20T03:11:54Z","timestamp":1789873914917,"version":"4.0.1"},"reference-count":20,"publisher":"Springer Science and Business Media LLC","issue":"6","license":[{"start":{"date-parts":[[2023,4,6]],"date-time":"2023-04-06T00:00:00Z","timestamp":1680739200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,4,6]],"date-time":"2023-04-06T00:00:00Z","timestamp":1680739200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100005187","name":"University of Athens","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100005187","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Ann Hematol"],"published-print":{"date-parts":[[2023,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Oral iron supplementation is the cornerstone for the management of iron-deficiency anemia. A new oral formulation of iron conjugated with N-aspartyl-casein (Fe-ASP) (Omalin\u00ae, Uni-Pharma) is studied in the ACCESS double-blind, double-dummy randomized clinical trial; 60 patients were randomized to 12-week oral treatment twice every day either with oral ferrous sulfate (FeSO\n                    <jats:sub>4<\/jats:sub>\n                    ) delivering 47 mg elementary iron or oral Fe-ASP delivering 40 mg elementary iron. Participants had hemoglobin less than 10 g\/dl, decreased red blood cell (RBC) count, and ferritin lower than 30 ng\/ml; patients with a medical history of malignancy were excluded. The primary endpoint was the increase of Hb in the first 4 weeks of treatment, and the study was powered for non-inferiority. A new score of global improvement was introduced where all participants were given one point for any at least 10% increase of Hb, RBC, and reticulocytes. At week 4, the mean (SE) change of Hb was 0.76 g\/dl in the FeSO\n                    <jats:sub>4<\/jats:sub>\n                    group and 0.83 g\/dl in the Fe-ASP group (\n                    <jats:italic>p<\/jats:italic>\n                    : 0.876). The odds for worse allocation of the global score were 0.35 in the Fe-ASP group compared to the FeSO\n                    <jats:sub>4<\/jats:sub>\n                    group. Patients in the Fe-ASP group experienced a significant decrease in the number of IDA-related physical signs by week 4. No differences were found between the two groups in any of the patient-reported outcomes of fatigue and of gastrointestinal adverse events either at week 4 or at week 12. ACCESS is the most recent clinical trial showing the non-inferiority of Fe-ASP to FeSO\n                    <jats:sub>4<\/jats:sub>\n                    for the primary endpoint of the Hb change.\n                  <\/jats:p>","DOI":"10.1007\/s00277-023-05197-3","type":"journal-article","created":{"date-parts":[[2023,4,6]],"date-time":"2023-04-06T07:02:48Z","timestamp":1680764568000},"page":"1341-1349","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["An active new formulation of iron carried by aspartyl casein for iron-deficiency anemia: results of the ACCESS trial"],"prefix":"10.1007","volume":"102","author":[{"given":"Maria","family":"Tsilika","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Mitrou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nikolaos","family":"Antonakos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ioulia K.","family":"Tseti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Georgia","family":"Damoraki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Konstantinos","family":"Leventogiannis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4713-3911","authenticated-orcid":false,"given":"Evangelos J.","family":"Giamarellos-Bourboulis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,4,6]]},"reference":[{"key":"5197_CR1","doi-asserted-by":"publisher","first-page":"583","DOI":"10.1111\/ejh.12776","volume":"97","author":"M Levi","year":"2016","unstructured":"Levi M, Rosselli M, Simonetti M, Brignoli O, Cancian M, Masotti A, Pegoraro V, Cataldo N, Heiman F, Chelo M, Cricelli I, Cricelli C, Lapi F (2016) Epidemiology of iron deficiency anaemia in four European countries: a population-based study in primary care. 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J. Giamarellos-Bourboulis has received honoraria from Abbott CH, bioM\u00e9rieux, Brahms GmbH, GSK, InflaRx GmbH, Sobi, and XBiotech Inc; independent educational grants from Abbott CH, AxisShield, bioM\u00e9rieux Inc, InflaRx GmbH, Johnson & Johnson, MSD, Sobi, and XBiotech Inc.; and funding from the Horizon2020 Marie-Curie Project European Sepsis Academy (granted to the National and Kapodistrian University of Athens), and the Horizon 2020 European Grants ImmunoSep and RISKinCOVID (granted to the Hellenic Institute for the Study of Sepsis). J. K. Tsetis is the CEO of Uni-Pharma SA.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}