~38 spots leftby Apr 2026

Vitamin D for Lymphoma

Recruiting in Palo Alto (17 mi)
+4 other locations
TW
Overseen byThomas E. Witzig, M.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Mayo Clinic
Must be taking: Vitamin D
Disqualifiers: Burkitt lymphoma, others
No Placebo Group
Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This partially randomized clinical trial studies cholecalciferol in improving survival in patients with newly diagnosed cancer with vitamin D insufficiency. Vitamin D replacement may improve tumor response and survival and delay time to treatment in patients with cancer who are vitamin D insufficient.

Do I need to stop my current medications for the Vitamin D for Lymphoma trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, you can participate in other therapies for your disease as long as they do not involve vitamin D.

What data supports the effectiveness of the drug Cholecalciferol (Vitamin D3) for treating lymphoma?

Research suggests that higher vitamin D levels are linked to better survival outcomes in certain types of lymphoma, such as follicular lymphoma and extranodal natural killer/T-cell lymphoma. This implies that maintaining adequate vitamin D levels might improve prognosis in these conditions.12345

Is Vitamin D3 safe for humans?

Vitamin D3 (Cholecalciferol) is generally considered safe for humans and is widely used as a supplement. It has been studied for its potential benefits in various conditions, including cancer, and no significant safety concerns have been reported in the research provided.23678

How does the drug Cholecalciferol differ from other treatments for lymphoma?

Cholecalciferol (Vitamin D3) is unique because it focuses on addressing vitamin D deficiency, which has been linked to poorer survival outcomes in certain types of lymphoma, like extranodal natural killer/T-cell lymphoma. Unlike traditional chemotherapy or radiation, this drug aims to improve patient outcomes by potentially enhancing vitamin D levels, which may have protective effects against lymphoma.247910

Research Team

TW

Thomas E. Witzig, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

Willing to provide blood samples for correlative research purposes
I have been recently diagnosed with aggressive lymphoma or CLL/SLL.
I can swallow pills without any issues.
See 3 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Vitamin D insufficient patients receive cholecalciferol orally once weekly for 12 weeks and then once monthly for a total of 36 months

36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

  • Cholecalciferol (Vitamin Supplement)
Trial OverviewThe 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.
Participant Groups
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.

Cholecalciferol is already approved in Canada, Japan, China, Switzerland for the following indications:

🇨🇦
Approved in Canada as Vitamin D3 for:
  • Prevention and treatment of vitamin D deficiency
  • Osteoporosis prevention
  • Rickets prevention
🇯🇵
Approved in Japan as Cholecalciferol for:
  • Prevention and treatment of vitamin D deficiency
  • Osteoporosis prevention
  • Rickets prevention
🇨🇳
Approved in China as Vitamin D3 for:
  • Prevention and treatment of vitamin D deficiency
  • Osteoporosis prevention
  • Rickets prevention
🇨🇭
Approved in Switzerland as Cholecalciferol for:
  • Prevention and treatment of vitamin D deficiency
  • Osteoporosis prevention
  • Rickets prevention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable profile image

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
Dr. Douglas R. Lowy profile image

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli profile image

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

In two independent cohorts of untreated follicular lymphoma patients, low vitamin D levels were associated with worse progression-free survival (PFS) and overall survival, suggesting that vitamin D may influence lymphoma outcomes.
The study indicates that vitamin D deficiency could be a modifiable factor affecting survival in follicular lymphoma, warranting further research into the potential benefits of vitamin D supplementation.
Low Serum Vitamin D Levels Are Associated With Inferior Survival in Follicular Lymphoma: A Prospective Evaluation in SWOG and LYSA Studies.Kelly, JL., Salles, G., Goldman, B., et al.[2022]
This systematic review of 15 studies involving 4503 patients found that low vitamin D levels (below 20 ng/mL) are significantly associated with worse outcomes in lymphoid malignancies, including a nearly doubled risk of disease progression and lower overall survival rates.
Supplemental vitamin D may enhance the effectiveness of chemotherapy, particularly in patients with diffuse large B-cell lymphoma (DLBCL) undergoing R-CHOP treatment, suggesting that maintaining adequate vitamin D levels could be crucial for improving treatment responses and patient survival.
A Systematic Review Assessing the Impact of Vitamin D Levels on Adult Patients with Lymphoid Malignancies.Potre, C., Borsi, E., Potre, O., et al.[2023]
In a study of 1127 lymphoma cases and matched controls with an average follow-up of 7.1 years, no overall protective association was found between plasma 25-hydroxyvitamin D (25(OH)D) levels and lymphoid cancer risk.
However, higher levels of 25(OH)D were linked to a significantly reduced risk of chronic lymphocytic leukemia (CLL), suggesting that while vitamin D may not protect against all lymphoid cancers, it could have a specific beneficial effect on CLL.
Plasma 25-hydroxyvitamin D concentration and lymphoma risk: results of the European Prospective Investigation into Cancer and Nutrition.Łuczyńska, A., Kaaks, R., Rohrmann, S., et al.[2023]

References

Low Serum Vitamin D Levels Are Associated With Inferior Survival in Follicular Lymphoma: A Prospective Evaluation in SWOG and LYSA Studies. [2022]
A Systematic Review Assessing the Impact of Vitamin D Levels on Adult Patients with Lymphoid Malignancies. [2023]
Plasma 25-hydroxyvitamin D concentration and lymphoma risk: results of the European Prospective Investigation into Cancer and Nutrition. [2023]
Vitamin D deficiency is associated with inferior survival of patients with extranodal natural killer/T-cell lymphoma. [2022]
Bioavailable 25(OH)D level is associated with clinical outcomes of patients with diffuse large B-cell lymphoma: An exploratory study. [2021]
Anticlastogenic potential of 1alpha,25-dihydroxyvitamin D3 in murine lymphoma. [2019]
A prospective investigation of serum 25-hydroxyvitamin D and risk of lymphoid cancers. [2021]
Vitamin D levels in Swiss breast cancer survivors. [2018]
Vitamin D levels in patients with non-Hodgkin lymphoma/diffuse large B-cell lymphoma, chronic lymphocytic leukemia and multiple myeloma. [2021]
Vitamin D and non-Hodgkin lymphoma risk in adults: a review. [2021]