A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's Lymphoma

Part of paid clinical trials in Miami, Florida.

Sponsor
Jonathan Friedberg
Study ID
NCT03078855
Phase
PHASE3
Status
Completed

Conditions

  • Follicular Lymphoma
  • Marginal Zone Lymphoma
  • Mucosal-Associated Lymphoid Tissue Lymphoma
  • Small Lymphocytic Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vitamin D — DIETARY_SUPPLEMENT
    vitamin D3 2,000 IU daily
  • Rituximab — BIOLOGICAL
    Administered weekly x 4
  • Placebo — OTHER
    methylcellulose

Study Details

Despite strong evidence suggesting that vitamin D deficiency is associated with undesirable outcomes in patients with numerous cancers, there has never been a thorough study of vitamin D treatment in subjects undergoing treatment for cancer. The purpose of this study is to evaluate whether modification of vitamin D levels in the blood, through supplementation, can improve outcomes.

Key Dates

Start date
Sep 7, 2017
Status verified
Aug 2024
Primary completion
Jul 21, 2023
Completion
Jul 2, 2024

Study Design

Enrollment
211 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Vitamin D plus rituximab
    Rituximab was administered weekly x 4 (intravenous 375 mg/m\^2 or subcutaneous equivalent) per institutional standards and vitamin D3, 2000 IU orally once daily. Participants took vitamin D3 until lack of response at week 13, disease progression, or initiation of a new treatment.
  • Placebo Comparator: Placebo plus rituximab
    Rituximab was administered weekly x 4 (intravenous 375 mg/m\^2 or subcutaneous equivalent) per institutional standards and placebo orally once daily. Participants took placebo until lack of response at week 13, disease progression, or initiation of a new treatment.

Primary Outcome Measure

Event Free Survival [ Time Frame: 3 years ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136-
Emory University, Winship Cancer InstituteAtlantaGeorgia30322-
University of IowaIowa CityIowa52242-
Washington UniversitySt LouisMissouri63130-
Weill Cornell Medical CollegeNew YorkNew York10021-
James P. Wilmot Cancer Institute at University of Rochester Medical CenterRochesterNew York14642-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Miami, FL

By research site
University of Miami· Miami, FLEmory University, Winship Cancer Institute· Atlanta, GAUniversity of Iowa· Iowa City, IAWashington University· St Louis, MOWeill Cornell Medical College· New York, NYJames P. Wilmot Cancer Institute at University of Rochester Medical Center· Rochester, NY

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