Vitamin D 25-Hydroxylase DeficiencyNCT07366450
High-Dose vs Standard Ergocalciferol for Vitamin D Normalization in Aggressive Non-Hodgkin Lymphoma
A study testing High-Dose Loading Ergocalciferol and Standard Weekly Ergocalciferol in people with Vitamin D 25-Hydroxylase Deficiency and Lymphoma Non-Hodgkin, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Vitamin D 25-Hydroxylase Deficiency, Lymphoma Non-Hodgkin
- What is being tested?
- High-Dose Loading Ergocalciferol and Standard Weekly Ergocalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteThailand
- Study dates
- 1 Feb 2026to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Phramonkutklao Hospital
Bangkok, 10400
Tanapun Thamgrang, MD, 66859930142, tanapun.tham@pcm.ac.th
Tanapun Thamgrang, MD
About this study
Official title: 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
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:
Read more
- 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
- Being tested
- High-Dose Loading Ergocalciferol, Standard Weekly Ergocalciferol
- Keywords
- Non-Hodgkin lymphoma, Vitamin D deficiency, Overall survival, Efficacy
- Medical subject headings
- Vitamin D Hydroxylation-Deficient Rickets, Type 1B, Lymphoma, Non-Hodgkin, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Dose Loading ErgocalciferolDrug
Dose and Schedule:
- Loading phase: Ergocalciferol 20,000 IU orally once daily (1 capsule per dose), administered 1-2 hours before breakfast, for 7 consecutive days.
- 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.
- Maintenance phase: After completion of the initial 6-week treatment period, ergocalciferol 20,000 IU orally once weekly (Monday) until completion of lymphoma treatment.
- 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.
Standard Weekly ErgocalciferolDrug
Dose and Schedule:
- 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.
- Maintenance phase: After completion of the 6-week standard dosing period, ergocalciferol 20,000 IU orally once weekly (Monday) until completion of lymphoma treatment.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: High-Dose Loading Ergocalciferol |
| 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. Receives: Drug: Standard Weekly Ergocalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Achieving Vitamin D Normalization by Day 21
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).
Measured: Day 21 (± 3 days) after the first dose of study medication
Secondary outcomes (7)
Event-Free Survival (EFS)
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.
Measured: Up to 3 years
Progression-Free Survival (PFS)
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.
Measured: Up to 3 years
Overall Survival (OS)
Overall survival is defined as the time from randomization to death from any cause.
Measured: Up to 3 years
Best Overall Response (BOR)
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.
Measured: Through the completion of first-line immunochemotherapy, approximately 24 weeks
Change in Serum 25-Hydroxyvitamin D Level
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).
Measured: Day 21 (± 3 days), Day 42 (± 3 days), Day 63 (± 3 days), and Day 126 (± 3 days) (end of treatment)
Incidence of Grade ≥ 3 Infections
Incidence of infections graded ≥ 3 according to the Common Terminology Criteria for Adverse Events (CTCAE), version 6.0.
Measured: From randomization through 30 days after the last dose of study treatment, approximately 22 weeks
Safety and Treatment-Related Toxicity
Safety and toxicity will be assessed based on the incidence of hypercalcemia, hypophosphatemia, and other adverse events, graded according to CTCAE version 6.0.
Measured: From randomization through 30 days after the last dose of study treatment, approximately 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D 25-Hydroxylase DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phramongkutklao College of Medicine and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tanapun Thamgrang, Principal investigator, Division of Hematology, Department of Medicine, Phramongkutklao Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366450
- Sponsor's protocol ID
- Hemato-002
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to institutional policy and privacy concerns. Only aggregate data may be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07366450
- Acronym / sponsor ID
- Hemato-002
- Keywords
- Non-Hodgkin lymphoma, Vitamin D deficiency, Overall survival, Efficacy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Phramongkutklao College of Medicine and HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Dose Loading Ergocalciferol | Experimental | Drug: High-Dose Loading ErgocalciferolParticipants 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. |
| Standard Weekly Ergocalciferol | Active comparator | Drug: Standard Weekly ErgocalciferolParticipants receive standard weekly dosing of ergocalciferol (vitamin D₂) for vitamin D normalization, in combination with standard first-line chemoimmunotherapy for aggressive non-Hodgkin lymphoma. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Dose Loading ErgocalciferolDose and Schedule: * Loading phase: Ergocalciferol 20,000 IU orally once daily (1 capsule per dose), administered 1-2 hours before breakfast, for 7 consecutive days. * 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. * Maintenance phase: After completion of the initial 6-week treatment period, ergocalciferol 20,000 IU orally once weekly (Monday) until completion of lymphoma treatment. * 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. | Drug | High-Dose Loading Ergocalciferol |
| Standard Weekly ErgocalciferolDose and Schedule: * 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. * Maintenance phase: After completion of the 6-week standard dosing period, ergocalciferol 20,000 IU orally once weekly (Monday) until completion of lymphoma treatment. * 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. | Drug | Standard Weekly Ergocalciferol |
Primary outcome
Proportion of Participants Achieving Vitamin D Normalization by Day 21
Time frame: Day 21 (± 3 days) after the first dose of study medication
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).
7 secondary outcomes
Event-Free Survival (EFS)
Time frame: Up to 3 years
Progression-Free Survival (PFS)
Time frame: Up to 3 years
Overall Survival (OS)
Time frame: Up to 3 years
Best Overall Response (BOR)
Time frame: Through the completion of first-line immunochemotherapy, approximately 24 weeks
Change in Serum 25-Hydroxyvitamin D Level
Time frame: Day 21 (± 3 days), Day 42 (± 3 days), Day 63 (± 3 days), and Day 126 (± 3 days) (end of treatment)
Incidence of Grade ≥ 3 Infections
Time frame: From randomization through 30 days after the last dose of study treatment, approximately 22 weeks
Safety and Treatment-Related Toxicity
Time frame: From randomization through 30 days after the last dose of study treatment, approximately 22 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to institutional policy and privacy concerns. Only aggregate data may be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tanapun Thamgrang principal investigator
Division of Hematology, Department of Medicine, Phramongkutklao Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Dose Loading Ergocalciferol and Standard Weekly Ergocalciferol in people with Vitamin D 25-Hydroxylase Deficiency and Lymphoma Non-Hodgkin, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tanapun Thamgrang, MD (66859930142, tanapun.tham@pcm.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Achieving Vitamin D Normalization by Day 21 (time frame: Day 21 (± 3 days) after the first dose of study medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.