Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 9:04 PM
Study NCT ID:
NCT07366450
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-26
First Post:
2026-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-Dose vs Standard Ergocalciferol for Vitamin D Normalization in Aggressive Non-Hodgkin Lymphoma
Sponsor:
Phramongkutklao College of Medicine and Hospital
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: