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Vitamin d boost may extend life in lymphoma patients, trial hopes

NCT ID NCT01787409

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

565 people

The number who actually took part.

Started

Mar 2013

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Emory University/Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259, United States

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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Other studies related to the condition(s) this trial covers.