About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- High-Dose Loading Ergocalciferol
- Standard Weekly Ergocalciferol