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Vitamin D for Lymphoma

N/A
Waitlist Available
Led By Julie Vose
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
History of Paget?s disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from the time of study entry of watch and wait or diagnosed non-hodgkin lymphoma or chronic lymphocytic leukemia until relapse, progression, or death from any cause, assessed at 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying how well cholecalciferol works in treating patients with newly diagnosed non-Hodgkin lymphoma or chronic lymphocytic leukemia with low levels of vitamin D.

Who is the study for?
This trial is for newly diagnosed or untreated patients with non-Hodgkin lymphoma or chronic lymphocytic leukemia who also have vitamin D deficiency. They can join even if they're on 'wait and watch' therapy, had up to two chemo cycles, or localized radiation. However, those with a history of severe allergic reactions to vitamin D, Paget's disease, high calcium levels in the blood, or conditions that could affect protocol adherence cannot participate.
What is being tested?
The study tests how well Cholecalciferol (a form of Vitamin D) works alongside standard chemotherapy in improving survival rates for patients with certain types of leukemia and lymphoma who are deficient in Vitamin D. It's an early phase I trial where some participants will receive Cholecalciferol while their responses are monitored through lab analysis.
What are the potential side effects?
Potential side effects may include issues related to high levels of vitamin D such as nausea, vomiting, constipation, weakness and serious complications like kidney damage; however specific side effects from this treatment aren't detailed.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of Paget's disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from the time of study entry of watch and wait or newly diagnosed non-hodgkin lymphoma or chronic lymphocytic leukemia administered on trial until death from any cause, assessed at 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from the time of study entry of watch and wait or newly diagnosed non-hodgkin lymphoma or chronic lymphocytic leukemia administered on trial until death from any cause, assessed at 3 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
Progression-free survival
Secondary study objectives
Incidence of adverse events and serious events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Overall survival

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
7%
Leg Cramps
7%
Viral Infection
7%
Hypercalcemia
7%
Allergic Infection
7%
Polydipsia
7%
Dehydration
7%
Urinary Tract Infection
3%
Chest Pain
3%
Sinusitis
3%
Headache
3%
General Infection
3%
Asthenia
3%
Fever
3%
Infection Fungal
3%
Conjuctivitis
3%
Syncope
3%
Depression
3%
Increased Cough
3%
Polyuria
3%
Abdominal Pain
3%
Photophobia
3%
Decreased libido
3%
Hypotension
3%
Nausea
3%
Esophageal ulcer
3%
Somnolence
3%
Back Pain
3%
Vomiting
3%
Pruritus
100%
80%
60%
40%
20%
0%
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

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (low-dose cholecalciferol)Experimental Treatment2 Interventions
Patients receive low-dose cholecalciferol PO daily for 3 years in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (high-dose cholecalciferol)Experimental Treatment2 Interventions
Patients receive high-dose cholecalciferol PO daily for 3 years in the absence of disease progression or unacceptable toxicity.
Group III: Arm III (control)Active Control1 Intervention
Patients receive no intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cholecalciferol
2014
Completed Phase 4
~1100

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor
555 Previous Clinical Trials
1,145,167 Total Patients Enrolled
4 Trials studying Vitamin D Deficiency
663 Patients Enrolled for Vitamin D Deficiency
National Cancer Institute (NCI)NIH
13,907 Previous Clinical Trials
41,011,947 Total Patients Enrolled
2 Trials studying Vitamin D Deficiency
150 Patients Enrolled for Vitamin D Deficiency
Julie VosePrincipal InvestigatorUniversity of Nebraska
6 Previous Clinical Trials
231 Total Patients Enrolled

Media Library

Cholecalciferol Clinical Trial Eligibility Overview. Trial Name: NCT02553447 — N/A
Vitamin D Deficiency Research Study Groups: Arm I (high-dose cholecalciferol), Arm II (low-dose cholecalciferol), Arm III (control)
Vitamin D Deficiency Clinical Trial 2023: Cholecalciferol Highlights & Side Effects. Trial Name: NCT02553447 — N/A
Cholecalciferol 2023 Treatment Timeline for Medical Study. Trial Name: NCT02553447 — N/A
~5 spots leftby Mar 2025
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