[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605505":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":20,"responsibleParty":30,"collaborators":20,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":38,"eligibilityCriteria":39,"healthyVolunteers":34,"sex":40,"minAge":41,"maxAge":42,"enrollmentInfo":43,"targetDuration":20,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":20,"overallStatus":53,"whyStopped":20,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":20},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"iron deficiency anemia in pregnancy","EXPERIMENTAL","Women with ongoing pregnancy attending at Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome will be prospectively enrolled from 24 to 32 weeks of pregnancy whether their hemoglobin levels are comprised between 8.5 and 10.5 g\u002Fdl. Patients will discontinue any other ongoing oral supplementation.",[13],"Combination Product: Sideral Folico",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"COMBINATION_PRODUCT","Sideral Folico","Pregnant women will be enrolled from 24 to 32 weeks of gestation whether their hemoglobin levels are comprised between 8.5 and 10.5 g\u002Fdl. They start oral supplementation with Sucrosomial iron® 30 mg (Sideral® Folico), 2 sticks for twice a day for 15 days, followed by Sucrosomial iron ® 30 mg (Sideral® Folico), 1 stick for twice a day for the next 15 days",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Giancarlo Paradisi","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","+39 0630155590","giancarlo.paradisi@policlinicogemelli.it",{"type":31,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100605505","iron-deficiency-anemia-in-the-second-and-third-trimester-of-pregnancy-100605505",false,"NCT07163390","Iron Deficiency Anemia in the Second and Third Trimester of Pregnancy","Iron Deficiency Anemia in the Second and Third Trimester of Pregnancy: Evaluation of the Contribution of Sucrosomial Iron Supplementation (Sideral® Folico)","PESO","Inclusion Criteria:\n\n* Pregnant women from 24 to 32 weeks of pregnancy\n* Age ≥18 ys old\n* Hemoglobin between 8.5 and 10.5 g\u002Fdl\n* Ability to sign an informed written consent\n\nExclusion Criteria:\n\n* Patients with preclampsia\n* twin pregnancy\n* chronic diseases\n* drug exposure\n* BMI\\\u003C18 or \\>30\n* malabsorption\n* fetal growth restriction\n* age \\\u003C 18 years\n* haematologic diseases\n* symptomatic anemia (dyspnea, tachycardia)\n* inability to sign an informed written consent","FEMALE","18 Years","50 Years",{"count":44,"type":45},82,"ESTIMATED","INTERVENTIONAL",[48],"NA","Iron deficiency is the most frequent cause of anemia during pregnancy and of maternal blood transfusion during the post-partum period. Intravenous administration is the fastest route to correct iron deficiency, bypassing the filter of iron intestinal absorption, the only true mechanism of iron balance regulation in the human body. Intravenous iron administration is suggested in patients who are refractory\u002Fintolerant to oral iron sulfate. This approach is expected to increase of at least 1 gr\u002FdL the level of hemoglobin in 4 weeks. However, the intravenous route of iron administration has some drawbacks; first it is allowed only as in-hospital procedure and requires a resuscitation service, in accordance with the recommendations of the European Medicine Agency. Moreover, it is very expensive and negatively affects patient's perceived quality of life. A new oral iron formulation, Sucrosomial iron, bypassing the normal route of absorption, appears to be better tolerated and more cost-effective in correcting iron deficiency anemia at doses higher than those usually effective with other oral iron formulations. The hypothesis of the present study is that oral sucrosomial iron can correct iron deficiency anemia during pregnancy comparably to intravenous ferrous sulphate, with less side effects.",[51,52],"Anemia, Iron Deficiency","Pregnancy Anemia","NOT_YET_RECRUITING","2025-09-01",{"date":56,"type":57},"2025-09-09","ACTUAL",{"date":59,"type":45},"2025-09-15",{"date":61,"type":45},"2027-09-15",{"name":5,"class":6}]