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Vitamin Supplement

Vitamin D for Lymphoma

N/A

Recruiting

Led By Thomas Witzig

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Newly diagnosed aggressive lymphoma or CLL/small lymphocytic lymphoma (SLL) that meets disease specific criteria

Capable of swallowing intact study medication capsules

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether vitamin D can improve survival in patients with newly diagnosed cancer who are insufficient in vitamin D.

Who is the study for?

This trial is for newly diagnosed patients with aggressive lymphoma or chronic lymphocytic leukemia/small lymphocytic lymphoma who can swallow capsules, are willing to return for follow-up and provide blood samples. They must have normal serum calcium levels and confirmed vitamin D insufficiency.

What is being tested?

The study tests if cholecalciferol (a form of vitamin D) improves survival, tumor response, and delays treatment in cancer patients with low vitamin D. It's a partially randomized trial that includes laboratory biomarker analysis to monitor effects.

What are the potential side effects?

Potential side effects may include hypercalcemia (high calcium levels), digestive issues, fatigue, or allergic reactions. However, since it's a form of vitamin D, many people tolerate it well.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been recently diagnosed with aggressive lymphoma or CLL/SLL.

Select...

I can swallow pills without any issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Event free survival (EFS) (Study I)

Treatment free status (Study II)

Secondary study objectives

Bio-R response rate (Study II)

EFS time (Study I)

OS (Study II)

+3 more

Other study objectives

Gene expression profiles

Immune effector cell levels

Serum cytokine profile

+2 more

Side effects data

From 2010 Phase 4 trial • 109 Patients • NCT01265615

23%

Hypophospatemia

17%

Fatigue

13%

Increased hypertension

13%

Edema

13%

Diarrhea

13%

Pain

10%

Taste perversions

10%

Arthritis

10%

Dizziness

10%

Gastroenteritis

10%

Vertigo

10%

Rhinitis

10%

Bronchitis

10%

Rash

Viral Infection

Leg Cramps

Hypercalcemia

Allergic Infection

Polydipsia

Dehydration

Urinary Tract Infection

Chest Pain

Sinusitis

Headache

General Infection

Asthenia

Fever

Infection Fungal

Conjuctivitis

Syncope

Depression

Increased Cough

Polyuria

Abdominal Pain

Photophobia

Decreased libido

Hypotension

Nausea

Esophageal ulcer

Somnolence

Back Pain

Vomiting

Pruritus

100%

80%

60%

40%

20%

Study treatment Arm

Paricalcitol Treatment

Calcitriol Treatment

Cholecalciferol

Supplemental

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (cholecalciferol)Experimental Treatment2 Interventions

Vitamin D sufficient patients receive no intervention. Vitamin D insufficient patients receive cholecalciferol PO once weekly for 12 weeks and then once monthly for a total of 36 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cholecalciferol

2014

Completed Phase 4

~1100

0 / 2Eligibility criteria met