The purpose of this study is to determine if Vitamin D supplementation improves clinical and immunologic parameters in chronic rhinosinusitis with nasal polyps.
Introductory Statement: Our laboratory has found that patients with chronic rhinosinusitis with nasal polyps (CRSwNP) have insufficient levels of vitamin D3. This is a proposal to conduct a placebo controlled trial on the use of vitamin D3 (5,000IU/day for 6 weeks) to determine clinical and immunologic outcomes in these patients. General Investigational Plan: We routinely examine vitamin D levels in all patients with CRSwNP. Those that are insufficient (less than 32 ng/ml) and have agreed to undergo sinus surgery will be randomized to placebo or vitamin D3 supplementation (5,000IU/day) for 6 weeks prior to surgery. Blood will be drawn pre- and post-supplementation to examine systemic immune parameters such as dendritic cell and T cell expression and cytokine levels. Sinus tissue will be collected at the time of surgery to analyze local immune parameters (dendritic cell, T cell and cytokine levels) between supplemented and placebo groups. Clinical outcomes will be analyzed using quality of life questionnaires, endoscopic grading and nasal peak inspiratory flow pre- and post- supplementation. IRB approval for this research project is pending.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Vitamin D 5000IU/day for 6 weeks
Medical University of South Carolina
Charleston, South Carolina, United States
Clinical symptom score
Symptoms will be graded using Sinonasal Outcomes Test-22.
Time frame: 6 weeks
Nasal peak inspiratory flow
Measurement of maximal nasal peak inspiratory flow
Time frame: 6 weeks
Systemic and local immunologic parameters
Histologic analysis of sinus immune cells, as well as systemic measurement of immune cells.
Time frame: 6 weeks
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