Sign in

NCT01787409Active, not recruiting

Cholecalciferol in Improving Survival in Patients With Newly Diagnosed Cancer With Vitamin D Insufficiency

Effect of Vitamin D Replacement on Tumor Response and Survival Parameters for Vitamin D Insufficient Patients With Cancer

Source: ClinicalTrials.gov · Last updated 16 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
565 (actual)
First submitted
6 Feb 2013
Start date
6 Mar 2013
Primary completion date
30 Jun 2028
Lead sponsor
Mayo Clinic
NCT number
NCT01787409

What you commit to

  • Study type: Interventional
  • Participants enrolled: 565
  • From 6 Mar 2013 to the primary completion date, 30 Jun 2028
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Emory University/Winship Cancer Institute
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
University of Iowa/Holden Comprehensive Cancer Center
Coordinator of this site? Confirm its status
Iowa CityUnited StatesUnknown status
Mayo Clinic
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
Mayo Clinic in Arizona
Coordinator of this site? Confirm its status
ScottsdaleUnited StatesUnknown status
Washington University School of Medicine
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.