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A phase III double blind, prospective randomized trial to evaluate the supplemental effect of vitamin D (cholecalciferol) on progression-free survival in patients with low tumor-burden indolent non-Hodgkin lymphoma treated with rituximab therapy
Clinical Trial 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.
-Randomization arms
-Placebo- Yes
-A placebo is a substance that looks like the study supplement but doesn’t include any active ingredients.
-Oral daily dose of either 2,000 IU vitamin D supplementation or placebo
-Complete study visit every 3 months
-Length of time on treatment is approximately 3 years or until you stop responding to treatment and not experiencing unacceptable side effects.
- Men and women 18 years old and older
- No prior anti-lymphoma systemic therapy; prior radiation therapy allowed
- Detailed eligibility reviewed when you contact the study team.
Study contact by location
Upper East Side - Manhattan
Primary Investigator(s)
John P Leonard, MD (UES)
Protocol ID(s)
Weill Cornell Medicine IRB #:
ClinicalTrials.gov:
Status
Open to Enrollment
Age Group
Sponsor
- National Institutes of Health (NIH)