[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621117":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":44,"responsibleParty":62,"collaborators":25,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":25,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":25,"enrollmentInfo":73,"targetDuration":25,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":88,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Phramongkutklao College of Medicine and Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"High-Dose Loading Ergocalciferol","EXPERIMENTAL","Participants receive a high-dose loading regimen of ergocalciferol (vitamin D₂) for rapid normalization of serum vitamin D levels, in combination with standard first-line chemoimmunotherapy for aggressive non-Hodgkin lymphoma.",[13],"Drug: High-Dose Loading Ergocalciferol",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Weekly Ergocalciferol","ACTIVE_COMPARATOR","Participants receive standard weekly dosing of ergocalciferol (vitamin D₂) for vitamin D normalization, in combination with standard first-line chemoimmunotherapy for aggressive non-Hodgkin lymphoma.",[19],"Drug: Standard Weekly Ergocalciferol",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Dose and Schedule:\n\n* Loading phase: Ergocalciferol 20,000 IU orally once daily (1 capsule per dose), administered 1-2 hours before breakfast, for 7 consecutive days.\n* Intensified phase: Following the loading phase, ergocalciferol 20,000 IU orally three times per week (Monday, Wednesday, and Friday) for a total treatment duration of 6 weeks from the first dose.\n* Maintenance phase: After completion of the initial 6-week treatment period, ergocalciferol 20,000 IU orally once weekly (Monday) until completion of lymphoma treatment.\n* Maximum duration of vitamin D₂ administration: Up to 18 weeks from the first dose of ergocalciferol. Thereafter, vitamin D dosing may be adjusted at the discretion of the treating physician.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Dose and Schedule:\n\n* Standard phase: Ergocalciferol 20,000 IU orally three times per week (Monday, Wednesday, and Friday), administered as 1 capsule per dose, 1-2 hours before breakfast, for a total duration of 6 weeks from the first dose.\n* Maintenance phase: After completion of the 6-week standard dosing period, ergocalciferol 20,000 IU orally once weekly (Monday) until completion of lymphoma treatment.\n* Maximum duration of vitamin D₂ administration: Up to 18 weeks from the first dose of ergocalciferol. Thereafter, vitamin D dosing may be adjusted at the discretion of the treating physician.",[15],[30],{"name":31,"affiliation":32,"role":33},"Tanapun Thamgrang","Division of Hematology, Department of Medicine, Phramongkutklao Hospital","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Tanapun Thamgrang, MD","CONTACT","66859930142","tanapun.tham@pcm.ac.th",{"name":41,"role":37,"phone":42,"phoneExt":25,"email":43},"Napakrit Tanpumiprated, MD","66881565102","napakrich@hotmail.com",[45],{"facility":46,"status":25,"city":47,"state":25,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Phramonkutklao Hospital","Bangkok","10400","Thailand","TH",{"type":52,"coordinates":53},"Point",[54,55],100.50144,13.75398,{"lat":55,"lon":54},[58,59,60],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},{"name":36,"role":33,"phone":25,"phoneExt":25,"email":25},{"name":41,"role":61,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"type":63,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100621117","high-dose-vs-standard-ergocalciferol-for-vitamin-d-normalization-in-aggressive-non-hodgkin-lymphoma-100621117",false,"NCT07366450","High-Dose vs Standard Ergocalciferol for Vitamin D Normalization in Aggressive Non-Hodgkin Lymphoma","Safety and Efficacy of High-Intensity Loading Dose Versus Standard Weekly Dosing of Ergocalciferol (Vitamin D2) for Vitamin D Normalization in Patients With Newly Diagnosed Aggressive Non-Hodgkin Lymphoma: A Randomized, Open-Label, Controlled Trial","Inclusion Criteria:\n\n* Age ≥ 20 years.\n* Newly diagnosed aggressive non-Hodgkin lymphoma, confirmed by histopathological examination according to the WHO Classification of Haematolymphoid Tumours, 5th edition, with an indication for standard first-line chemoimmunotherapy\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.\n* Serum 25-hydroxyvitamin D level \\\u003C 30 ng\u002FmL within 14 days prior to randomization.\n* Adequate organ function to receive full-dose standard chemotherapy.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Mild hypercalcemia (corrected Ca \\> 10.4 mg\u002FdL)\n* Hyperphosphatemia (PO4 \\> 4.5 mg\u002FdL)\n* History of urolithiasis associated with hypercalciuria or a diagnosis of primary hyperparathyroidism.\n* Chronic kidney disease stage 4 or higher (estimated glomerular filtration rate \\[eGFR\\] \\\u003C 30 mL\u002Fmin\u002F1.73 m²).\n* Inability to take oral medication, active gastrointestinal bleeding, or malabsorption syndrome.\n* Pregnancy or breastfeeding.\n* Prior systemic therapy for lymphoma.\n* Ongoing tumor lysis syndrome requiring urgent treatment.\n* Prior use of vitamin D supplements (ergocalciferol or cholecalciferol).\n\nWithdrawal Criteria:\n\n* Development of mild hypercalcemia.\n* Development of mild hypophosphatemia.\n* Development of hypervitaminosis D.\n* Occurrence of severe adverse events (AEs) or side effects for which the investigator considers discontinuation of the study drug necessary for patient safety.\n* Investigator's judgment that continued participation may pose a safety risk, such as the occurrence of serious infection, febrile neutropenia, or organ failure.\n* Non-adherence to study medication, defined as cumulative vitamin D₂ intake of less than 80% of the expected cumulative dose at the time of serum vitamin D assessment.\n* Participant withdrawal of consent to continue participation in the study.","ALL","20 Years",{"count":74,"type":75},52,"ESTIMATED","INTERVENTIONAL",[78],"NA","The goal of this clinical trial is to evaluate whether a high-intensity loading dose of ergocalciferol (vitamin D2) can normalize blood vitamin D levels more rapidly and safely than standard weekly dosing in patients with newly diagnosed aggressive non-Hodgkin lymphoma. The study will also assess the safety of both dosing strategies.\n\nThe main questions it aims to answer are:\n\n* Does a high-intensity loading dose of ergocalciferol lead to faster normalization of serum 25-hydroxyvitamin D levels compared with standard weekly dosing?\n* Are there differences in safety and adverse events between the two dosing strategies?\n\nResearchers will compare a high-intensity loading dose regimen of ergocalciferol with a standard weekly dosing regimen to determine differences in vitamin D normalization and safety outcomes.\n\nParticipants will:\n\n* Be randomly assigned to receive either a high-intensity loading dose or a standard weekly dose of ergocalciferol (vitamin D2)\n* Receive standard first-line immunochemotherapy for aggressive non-Hodgkin lymphoma\n* Have blood tests to monitor vitamin D levels, calcium, phosphate, and safety parameters at scheduled visits\n* Be followed for treatment response, survival outcomes, and adverse events during and after therapy",[81,82],"Vitamin D 25-Hydroxylase Deficiency","Lymphoma Non-Hodgkin",[84,85,86,87],"Non-Hodgkin lymphoma","Vitamin D deficiency","Overall survival","Efficacy","NOT_YET_RECRUITING","2026-01-16",{"date":91,"type":92},"2026-01-26","ACTUAL",{"date":94,"type":75},"2026-02-01",{"date":96,"type":75},"2029-07-31",{"name":5,"class":6},1]