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NOT YET RECRUITING
NCT07366450
NA

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

Sponsor: Phramongkutklao College of Medicine and Hospital

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2026-02-01

Completion Date

2029-07-31

Last Updated

2026-01-26

Healthy Volunteers

No

Interventions

DRUG

High-Dose Loading Ergocalciferol

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.

DRUG

Standard Weekly Ergocalciferol

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.

Locations (1)

Phramonkutklao Hospital

Bangkok, Thailand