Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 9:04 PM
Study NCT ID:
NCT07366450
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-26
First Post:
2026-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-Dose vs Standard Ergocalciferol for Vitamin D Normalization in Aggressive Non-Hodgkin Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'C564005', 'term': 'Vitamin D Hydroxylation-Deficient Rickets, Type 1B'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2029-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-16', 'studyFirstSubmitDate': '2026-01-05', 'studyFirstSubmitQcDate': '2026-01-16', 'lastUpdatePostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants Achieving Vitamin D Normalization by Day 21', 'timeFrame': 'Day 21 (± 3 days) after the first dose of study medication', 'description': 'Vitamin D normalization is defined as a serum 25-hydroxyvitamin D level ≥ 30 ng/mL. This outcome is assessed as a binary outcome (yes/no).'}], 'secondaryOutcomes': [{'measure': 'Event-Free Survival (EFS)', 'timeFrame': 'Up to 3 years', 'description': 'Event-free survival is defined as the time from randomization to the first occurrence of disease progression, relapse after response, initiation of new lymphoma therapy, or death from any cause.'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Up to 3 years', 'description': 'Progression-free survival is defined as the time from randomization to the first documented disease progression according to the Lugano 2014 criteria or death from any cause, whichever occurs first.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 3 years', 'description': 'Overall survival is defined as the time from randomization to death from any cause.'}, {'measure': 'Best Overall Response (BOR)', 'timeFrame': 'Through the completion of first-line immunochemotherapy, approximately 24 weeks', 'description': 'Best overall response is defined as the best response achieved after completion of first-line immunochemotherapy, including complete response (CR) or partial response (PR), as assessed by PET-CT or CT scan according to the Lugano 2014 criteria.'}, {'measure': 'Change in Serum 25-Hydroxyvitamin D Level', 'timeFrame': 'Day 21 (± 3 days), Day 42 (± 3 days), Day 63 (± 3 days), and Day 126 (± 3 days) (end of treatment)', 'description': 'Changes in serum 25-hydroxyvitamin D levels will be compared between study arms and summarized as absolute change and central tendency measures (mean or median).'}, {'measure': 'Incidence of Grade ≥ 3 Infections', 'timeFrame': 'From randomization through 30 days after the last dose of study treatment, approximately 22 weeks', 'description': 'Incidence of infections graded ≥ 3 according to the Common Terminology Criteria for Adverse Events (CTCAE), version 6.0.'}, {'measure': 'Safety and Treatment-Related Toxicity', 'timeFrame': 'From randomization through 30 days after the last dose of study treatment, approximately 22 weeks', 'description': 'Safety and toxicity will be assessed based on the incidence of hypercalcemia, hypophosphatemia, and other adverse events, graded according to CTCAE version 6.0.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-Hodgkin lymphoma', 'Vitamin D deficiency', 'Overall survival', 'Efficacy'], 'conditions': ['Vitamin D 25-Hydroxylase Deficiency', 'Lymphoma Non-Hodgkin']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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 \\< 30 ng/mL 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/dL)\n* Hyperphosphatemia (PO4 \\> 4.5 mg/dL)\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\\] \\< 30 mL/min/1.73 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."}, 'identificationModule': {'nctId': 'NCT07366450', 'briefTitle': 'High-Dose vs Standard Ergocalciferol for Vitamin D Normalization in Aggressive Non-Hodgkin Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Phramongkutklao College of Medicine and Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'Hemato-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-Dose Loading Ergocalciferol', 'description': '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.', 'interventionNames': ['Drug: High-Dose Loading Ergocalciferol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Weekly Ergocalciferol', 'description': '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.', 'interventionNames': ['Drug: Standard Weekly Ergocalciferol']}], 'interventions': [{'name': 'High-Dose Loading Ergocalciferol', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['High-Dose Loading Ergocalciferol']}, {'name': 'Standard Weekly Ergocalciferol', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Standard Weekly Ergocalciferol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'contacts': [{'name': 'Tanapun Thamgrang, MD', 'role': 'CONTACT', 'email': 'tanapun.tham@pcm.ac.th', 'phone': '66859930142'}, {'name': 'Tanapun Thamgrang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Napakrit Tanpumiprated, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Phramonkutklao Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Tanapun Thamgrang, MD', 'role': 'CONTACT', 'email': 'tanapun.tham@pcm.ac.th', 'phone': '66859930142'}, {'name': 'Napakrit Tanpumiprated, MD', 'role': 'CONTACT', 'email': 'napakrich@hotmail.com', 'phone': '66881565102'}], 'overallOfficials': [{'name': 'Tanapun Thamgrang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Hematology, Department of Medicine, Phramongkutklao Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared due to institutional policy and privacy concerns. Only aggregate data may be shared upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Phramongkutklao College of Medicine and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}