Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps — VDinCRS  

Chronic Sinusitis Clinical Trial

Official title: Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps

Status Withdrawn

Clinical Trial Summary

The purpose of this study is to determine if Vitamin D supplementation improves clinical and immunologic parameters in chronic rhinosinusitis with nasal polyps.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Sinusitis
• Nasal Polyps
• Sinusitis

• NCT number: NCT01185808
• Study type: Interventional
• Source: Medical University of South Carolina
• Status: Withdrawn
• Phase: N/A
• Start date: October 2013
• Completion date: October 2013