High-Dose vs Standard Ergocalciferol for Vitamin D Normalization in Aggressive Non-Hodgkin Lymphoma

Phramongkutklao College of Medicine and Hospital

Status: Not yet enrolling

Conditions: Lymphoma Non-Hodgkin; Vitamin D 25-Hydroxylase Deficiency

Treatments: Drug: High-Dose Loading Ergocalciferol; Drug: Standard Weekly Ergocalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT07366450

Hemato-002

Details and patient eligibility

About

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

Enrollment: 52 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

High-Dose Loading Ergocalciferol

Experimental group

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.

Treatment:

Drug: High-Dose Loading Ergocalciferol

Standard Weekly Ergocalciferol

Active Comparator group

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.

Treatment:

Drug: Standard Weekly Ergocalciferol