Vitamin D Supplementation 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.

Inclusion Criteria:

- Chronic sinusitis with polyps

Exclusion Criteria:

- Use of systemic steroids, or other immunmodulatory agents in preceding monthS, other
immunologic, renal, gastrointestinal, endocrine or skeletal disorder (rheumatoid
arthritis, immunodeficiency, cystic fibrosis, ciliary dyskinesia, malabsorption, etc.)

- Pregnancy or age less than 14 years.