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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. 

Key Eligibility: 

   - 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. 

Contact

Amelyn Rodriguez
amr2017@med.cornell.edu
212-746-1362

Primary Investigator

John Leonard, M.D.

Protocol ID(s)

Weill Cornell Medicine IRB #:

1709018567

ClinicalTrials.gov:

NCT03078855

Status:

Open to Enrollment

Age Group

Adult

Sponsor

Drug/Device

Drug

Study Type

Phase

3