Vitamin D3 (Vit D3) Supplementation and T Cell Immunomodulation in Patients With Newly Diagnosed Operative Invasive Ductal Breast Carcinoma Stage I-II
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Compare the differences in the T cell phenotype and function using PBMCs from patients in different cohorts
T cell analysis for the following markers will be evaluated- memory markers activation status and presence of regulatory T cells lymphoid organ-homing receptors Functional status of gated T cells will be analyzed cell surface thiol molecules and intracellular glutathione using flow cytometry to evaluate if anti-oxidant stus of the T cells is modulated in presence of the Vitamin D. These markers will help in determining the immunomodulatory potential of Vitamin D on T cell with respect to function, activation status and anti-oxidant capacity that can effect persistence and in turn immune outcome. The data obtained will be reported in terms of percent increase or decrease in number of T cells expressing particular receptors (homing or chemokine) or for differences in functional outcome (cytokine response) upon activation relative to samples collected at baseline.
Prior to Treatment (Baseline), Week 4 and Week 8
United States: Institutional Review Board
|Medical University of South Carolina||Charleston, South Carolina 29425-0721|