Vitamin d boost may extend life in lymphoma patients, trial hopes
NCT ID NCT01787409
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether giving vitamin D supplements to people with newly diagnosed lymphoma or chronic lymphocytic leukemia who have low vitamin D levels can improve their survival and delay the need for treatment. About 565 participants are being given vitamin D3 or a placebo. The goal is to see if correcting vitamin D insufficiency helps control the disease better.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vitamin D3 (cholecalciferol)
- What this could lead to
- If it works, this could show that correcting vitamin D levels helps people with certain cancers live longer or delay needing treatment.
- What could go wrong
- This is an early-stage study without a clear phase, and results may not apply to all cancers. Vitamin D is a supplement, so any benefit is likely modest and not a cure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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565 people
The number who actually took part.
- Started
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Mar 2013
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Newly diagnosed aggressive lymphoma or CLL/small lymphocytic lymphoma (SLL) that meets disease specific criteria below: * Study 1 - Aggressive lymphoma * Newly diagnosed de-novo DLBCL or primary mediastinal B-cell lymphoma that will be treated with an anthracycline-containing regimen (rituximab-cyclophosphamide, doxorubicin hydrochloride, prednisone \[R-CHOP\] or equivalent); patients with composite lymphomas can also be enrolled as long as they have large cell component and will be treated with an anthracycline; in addition, patients with "B cell lymphoma, unclassifiable, with features intermediate between diffuse large B cell lymphoma and Burkitt lymphoma" or post-transplant DLBCL are also eligible as long as they meet other criteria; patients with typical Burkitt lymphoma are not eligible * NOTE: patients can be enrolled up through day 1 of cycle 3 of therapy; the patient is permitted to participate in any other therapeutic therapy for their disease as long as it does not concern vitamin D; patients can begin their chemotherapy while awaiting vitamin D results and treatment arm assignment or * Newly diagnosed untreated peripheral T-cell non-Hodgkin lymphoma (NHL) that will be treated with chemotherapy; NOTE: patients can be enrolled up through day 1 of cycle 3 of therapy; this includes the following disease types: * Peripheral T cell lymphoma, unspecified * Anaplastic large cell lymphoma (T and null cell type) * Extranodal NK/T-cell lymphoma, nasal type * Enteropathy-type T-cell lymphoma * Hepatosplenic T-cell lymphoma * Subcutaneous panniculitis-like T-cell lymphoma * Angioimmunoblastic T-cell lymphoma * Anaplastic large cell lymphoma - primary cutaneous type and * Willing to provide tissue for correlative research purposes * Study 2 - CLL/SLL * Newly diagnosed (\< 12 months from pre-registration on this study) CLL according to the National Cancer Institute (NCI) criteria or SLL according to the World Health Organization (WHO) criteria; this includes previous documentation of: * Biopsy-proven small lymphocytic lymphoma * Diagnosis of CLL according to NCI working group criteria as evidenced by all of the following: * Peripheral blood lymphocyte count of \> 5,000/mm\^3; if present, prolymphocytes should be \< 55% * Immunophenotyping consistent with CLL defined as: * The predominant population of lymphocytes share both B-cell antigens (cluster of differentiation \[CD\]19, CD20, or CD23) as well as CD5 in the absence of other pan-T-cell markers (CD3, CD2, etc.) * Dim surface immunoglobulin expression * Restricted surface kappa or lambda light chain expression * Before diagnosing CLL or SLL, mantle cell lymphoma must be excluded by demonstrating a negative fluorescent in situ hybridization (FISH) analysis for t(11;14)(immunoglobulin H \[IgH\]/cyclin D 1 \[CCND1\]) on peripheral blood or tissue biopsy or negative immunohistochemical stains for cyclin D1 on involved tissue biopsy * Rai stage 0 or 1 * Previously untreated * Asymptomatic with the plan for observation * Life expectancy of at least 24 months * Willing to provide tissue for correlative research purposes * Both Studies: * Capable of swallowing intact study medication capsules * Serum calcium \< 11 mg/dL; note: patients with hypercalcemia can be enrolled after the calcium is corrected with standard of care treatments * Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) * Note: During the Active Monitoring Phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up * Willing to provide blood samples for correlative research purposes * Vitamin D level (25 hydroxy D2 + hydroxyl D3) confirmed by central laboratory review Exclusion Criteria: * Patients with Burkitt lymphoma or any patient receiving rituximab-cyclophosphamide, vincristine, doxorubicin, high-dose methotrexate / ifosfamide, etoposide, high-dose cytarabine (R- CODOXM/IVAC) * Patients who previously had indolent lymphoma and now at a separate episode have large cell NHL (i.e. transformation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
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University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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