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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
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
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
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
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival
Secondary outcome measures
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 • NCT0126561523%
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%
Viral Infection
7%
Leg Cramps
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
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
537 Previous Clinical Trials
1,143,757 Total Patients Enrolled
4 Trials studying Vitamin D Deficiency
712 Patients Enrolled for Vitamin D Deficiency
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,445 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have any other medical condition or mental illness that may make it difficult for you to follow the study protocol or understand the information provided to you.I have newly diagnosed or untreated non-Hodgkin’s lymphoma or CLL.I have a history of Paget's disease.You can participate in other clinical trials for different treatments at the same time.I have had a vitamin D level test at enrollment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (high-dose cholecalciferol)
- Group 2: Arm II (low-dose cholecalciferol)
- Group 3: Arm III (control)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the recruitment process for this trial ongoing?
"According to the information on clinicaltrials.gov, this trial is no longer recruiting participants. Initially posted in October 2015 and last updated on August 4th 2022, there are nonetheless 2952 alternative medical studies that still require volunteers."
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