[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555131":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":29,"locations":39,"responsibleParty":59,"collaborators":18,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":18,"enrollmentInfo":73,"targetDuration":18,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":89,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"St. Petersburg State Pavlov Medical University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Vitamin supplementation","EXPERIMENTAL","vitamin A 300 000 IU and vitamin D 100 000 IU on days -14 to -8 before transplantation",[13,14],"Drug: Vitamin A","Drug: Vitamin D3",{"label":16,"type":17,"description":16,"interventionNames":18},"Routine care","NO_INTERVENTION",null,[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Vitamin A","300 000 IU single dose orally",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":18},"Vitamin D3","100 000 IU single dose orally",[9],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"IVAN SERGEEVICH MOISEEV","CONTACT","+78123386265","moisiv@mail.ru",{"name":36,"role":32,"phone":37,"phoneExt":18,"email":38},"Irina Сергеевич Bykova","+78123386617","bmt-director@1spbgmu.ru",[40],{"facility":41,"status":42,"city":43,"state":18,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RM Gorbacheva Research Institute","RECRUITING","Saint Petersburg","197022","Russia","RU",{"type":48,"coordinates":49},"Point",[50,51],30.31413,59.93863,{"lat":51,"lon":50},[54,57],{"name":55,"role":32,"phone":56,"phoneExt":18,"email":34},"Ivan Moiseev","+79217961951",{"name":58,"role":32,"phone":33,"phoneExt":18,"email":38},"Alexandr Kulagin",{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Ivan S Moiseev","Vice-director of RM Gorbacheva Research Institute","100555131","phase-2-vitamin-a-and-d-supplementation-in-allogeneic-hct-100555131",false,"NCT06508099","Vitamin A and D Supplementation in Allogeneic HCT","Randomized Study of Vitamin A and D Prophylaxis Before Allogeneic Related and Unrelated Hematopoietic Stem Cell Transplantation","VitaStem","Inclusion Criteria:\n\n* Diagnosis: acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, chronic myeloproliferative disease, chronic myeloid leukemia, lymphoblastic lymphoma, myeloma\n* Standard disease risk: less than 5% clonal blasts in the bone marrow and the absence of blast forms in the peripheral blood at the time of inclusion in the study or at least partial response for lymphoproliferative neoplasms.\n* Related compatible donor 10\u002F10 HLA-matched or unrelated compatible donor 9-10\u002F10 HLA-matched\n* Age ≥18 years\n* Absence of severe concomitant somatic diseases\n\nExclusion Criteria:\n\n* \\- Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 normal;\n* respiratory failure more than 1 degree. or oxygen dependence\n* Unstable hemodynamics;\n* Uncontrolled bacterial or fungal infection at the time of inclusion, despite adequate antibacterial or antifungal therapy (CRP\\>70 mg\u002Fl at the time of inclusion).\n* Karnofsky index less than 70%\n* Repeated allogeneic transplantation of hematopoietic cells;\n* Creatinine clearance below 60ml\u002Fmin\u002F1.73m2;\n* Severe cardiac pathology, including a decrease in ejection fraction less than \\\u003C50%, unstable angina, exertional angina of III-IV functional class, heart failure of III-IV functional class, arrhythmia grade V according to Lawn\n* Severe decrease in lung function, FEV1 \\\u003C50% or DLCO\\\u003C50% predicted\n* Pregnancy\n* Somatic or mental pathology that does not allow signing informed consent","ALL","18 Years",{"count":74,"type":75},220,"ESTIMATED","INTERVENTIONAL",[78],"PHASE2","The therapy under investigation is the addition of 300 000 IU of vitamin A and 100 000 IU of vitamin D before conditioning. The study will include patients with malignant diseases in hematologic response with indications for allogeneic transplantation with matched related or matched unrelated donor.",[81,82,83,84,85,86,87,88],"Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","Biphenotypic Acute Leukemia","Lymphoblastic Lymphoma","Chronic Myeloid Leukemia","Myelodysplastic Syndromes","Myeloprolipherative Neoplsm","Non-hodgkin Lymphoma",[90,91,92],"allogeneic hematopoietic transplantation","vitamin A","vitamin D","2024-07-29",{"date":95,"type":96},"2024-07-31","ACTUAL",{"date":98,"type":96},"2024-05-15",{"date":100,"type":75},"2027-05",{"name":5,"class":6},1]