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

NCT07366450 | Not Yet Recruiting

• 1 other identifier: Hemato-002
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Conditions

Vitamin D 25-Hydroxylase Deficiency; Lymphoma Non-Hodgkin

Keywords

Non-Hodgkin lymphoma; Vitamin D deficiency; Overall survival; Efficacy

Outcome Measures

Primary Outcomes (1)

• 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).

  Day 21 (± 3 days) after the first dose of study medication

Secondary Outcomes (7)

• Event-Free Survival (EFS)

  Up to 3 years

• Progression-Free Survival (PFS)

  Up to 3 years

• Overall Survival (OS)

  Up to 3 years

• Best Overall Response (BOR)

  Through the completion of first-line immunochemotherapy, approximately 24 weeks

• Change in Serum 25-Hydroxyvitamin D Level

  Day 21 (± 3 days), Day 42 (± 3 days), Day 63 (± 3 days), and Day 126 (± 3 days) (end of treatment)

Study Arms (2)

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.

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.

Drug: Standard Weekly Ergocalciferol

Interventions

High-Dose Loading Ergocalciferol DRUG

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.

High-Dose Loading Ergocalciferol

Standard Weekly Ergocalciferol DRUG

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.

Standard Weekly Ergocalciferol

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Phramongkutklao College of Medicine and Hospital: lead

Study Sites (1)

Phramonkutklao Hospital

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Vitamin D Hydroxylation-Deficient Rickets, Type 1B; Lymphoma, Non-Hodgkin; Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Tanapun Thamgrang

  Division of Hematology, Department of Medicine, Phramongkutklao Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tanapun Thamgrang, MD

CONTACT

66859930142; tanapun.tham@pcm.ac.th

Napakrit Tanpumiprated, MD

CONTACT

66881565102; napakrich@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 26, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): July 31, 2029
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)