Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. The main questions it aims to answer are: * Does a high-intensity loading dose of ergocalciferol lead to faster normalization of serum 25-hydroxyvitamin D levels compared with standard weekly dosing? * Are there differences in safety and adverse events between the two dosing strategies? Researchers 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. Participants will: * Be randomly assigned to receive either a high-intensity loading dose or a standard weekly dose of ergocalciferol (vitamin D2) * Receive standard first-line immunochemotherapy for aggressive non-Hodgkin lymphoma * Have blood tests to monitor vitamin D levels, calcium, phosphate, and safety parameters at scheduled visits * Be followed for treatment response, survival outcomes, and adverse events during and after therapy
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma Non-Hodgkin | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Vitamin D 25-Hydroxylase Deficiency | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-Dose Loading Ergocalciferol | Drug | — | UNRESOLVED |
| Standard Weekly Ergocalciferol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- 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
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 20 years. * 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 * Eastern Cooperative Oncology Group (ECOG) performance status of 0-3. * Serum 25-hydroxyvitamin D level \< 30 ng/mL within 14 days prior to randomization. * Adequate organ function to receive full-dose standard chemotherapy. * Ability to provide written informed consent. Exclusion Criteria: * Mild hypercalcemia (corrected Ca \> 10.4 mg/dL) * Hyperphosphatemia (PO4 \> 4.5 mg/dL) * History of urolithiasis associated with hypercalciuria or a diagnosis of primary hyperparathyroidism. * Chronic kidney disease stage 4 or higher (estimated glomerular filtration rate \[eGFR\] \< 30 mL/min/1.73 m²). * Inability to take oral medication, active gastrointestinal bleeding, or malabsorption syndrome. * Pregnancy or breastfeeding. * Prior systemic therapy for lymphoma. * Ongoing tumor lysis syndrome requiring urgent treatment. * Prior use of vitamin D supplements (ergocalciferol or cholecalciferol). Withdrawal Criteria: * Development of mild hypercalcemia. * Development of mild hypophosphatemia. * Development of hypervitaminosis D. * Occurrence of severe adverse events (AEs) or side effects for which the investigator considers discontinuation of the study drug necessary for patient safety. * Investigator's judgment that continued participation may pose a safety risk, such as the occurrence of serious infection, febrile neutropenia, or organ failure. * 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. * Participant withdrawal of consent to continue participation in the study.
References
Publications (0)
Data not yet available