[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543060":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":11,"locations":28,"responsibleParty":52,"collaborators":11,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":11,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":11,"overallStatus":31,"whyStopped":11,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Centre Hospitalier Universitaire Vaudois","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with Roux-en-Y gastric bypass and iron deficiency 1","EXPERIMENTAL",null,[13],"Drug: Iron isomaltoside",{"label":15,"type":10,"description":11,"interventionNames":16},"Patients with Roux-en-Y gastric bypass and iron deficiency 2",[17],"Drug: Iron Carboxymaltose",[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","Iron isomaltoside","single dose of 500 mg iron isomaltoside",[9],{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Iron Carboxymaltose","single dose of 500 mg ferric carboxymaltose",[15],[29],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"CHUV","RECRUITING","Lausanne","Canton of Vaud","1003","Switzerland","CH",{"type":38,"coordinates":39},"Point",[40,41],6.63282,46.516,{"lat":41,"lon":40},[44,49],{"name":45,"role":46,"phone":47,"phoneExt":11,"email":48},"Lucie Favre, MD","CONTACT","+41 21 3140548","lucie.favre@chuv.ch",{"name":50,"role":46,"phone":11,"phoneExt":11,"email":51},"Sara Santini, MD","sara.santini@chuv.ch",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Lucie Favre","Co-director of the Obesity Center, CHUV","100543060","phase-4-iv-iron-induced-hypophosphatemia-after-rygb-100543060",false,"NCT06350955","IV Iron-induced Hypophosphatemia After RYGB","Intravenous Iron-induced Hypophosphatemia in Patients With Roux-en-Y Gastric Bypass: a Single-blind, Randomized Clinical Trial Comparing Iron Isomaltoside (Monofer®) and Ferric Carboxymaltose (Ferinject®)","IVORY","Inclusion Criteria:\n\n* Patients over 18 years\n* Signed informed consent\n* Patients with previous RYGB surgery performed \\> 12 months ago\n* Failed response to oral iron supplementation\n* Established diagnosis of iron deficiency by ferritin \\\u003C 50 ug\u002Fl or serum ferritin ≤100ug\u002Fl and low transferrin saturation (TSAT) ≤ 30%\n* Normal phosphate blood level (0.8 - 1.45 mmol\u002Fl) before infusion\n* Normal magnesium blood level (0.65-1.05 mmol\u002Fl)\n* Outpatient\n\nExclusion Criteria:\n\n* \\- Patients with known hypersensitivity to iron preparation and\u002For anaphylaxis from any cause\n* Patients for whom a treatment with one of the IV iron is contra-indicated (based on product summary of product characteristics)\n* Women who are pregnant or breastfeeding\n* Intention to become pregnant during the course of the study\n* Renal failure, chronic kidney disease stage 3b or worse (eGFR ≤ 45 ml\u002Fmin\u002F1.73m2)\n* Patients who received IV iron infusion during the last 3 months before screening\n* Treatment with erythropoietin or erythropoietin-stimulation agents, red blood cell transfusion within the last 3 months prior to screening\n* Alcohol or drug abuse within the past 6 months\n* Planned surgical procedure within the clinical trial period\n* Surgery under general anaesthesia within the last 3 months prior to screening\n* Hyperparathyroidism\n* Kidney transplantation\n* Inability to follow study procedures or give informed consent\n* Use and inability to stop from V0 to study end, phosphate supplementation (except daily multivitamin preparation recommended after bariatric surgery; the exact amount of phosphate and iron supplementation in the daily multivitamin will be recorded)\n* Osteoporosis drug therapy (bisphosphonates, denosumab or selective oestrogen receptor modulators).\n* Patient who refuses to be informed of incidental discoveries that may contribute to the prevention, diagnosis, and treatment of existing or probable future illnesses.","ALL","18 Years","99 Years",{"count":68,"type":69},94,"ESTIMATED","INTERVENTIONAL",[72],"PHASE4","The primary objective of the study is to compare the incidence of hypophosphatemia in RYGB patients treated with intravenous (IV) single dose of iron isomaltoside (Monofer®) or ferric carboxymaltose (Ferinject®).",[75,76],"Hypophosphatemia","Roux-en-Y Gastric Bypass","2024-08-19",{"date":79,"type":80},"2024-08-20","ACTUAL",{"date":82,"type":80},"2024-05-02",{"date":84,"type":69},"2026-06",{"name":54,"class":6},1]