High-Dose vs Standard Ergocalciferol for Vitamin D Normalization in Aggressive Non-Hodgkin Lymphoma (NCT07366450) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
High-Dose vs Standard Ergocalciferol for Vitamin D Normalization in Aggressive Non-Hodgkin Lymphoma
Thailand52 participantsStarted 2026-02-01
Plain-language summary
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
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 tha…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Participants Achieving Vitamin D Normalization by Day 21
Timeframe: Day 21 (± 3 days) after the first dose of study medication
Trial details
NCT IDNCT07366450
SponsorPhramongkutklao College of Medicine and Hospital