Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps
- Conditions
- Chronic Sinusitis
- Interventions
- Biological: Vitamin D
- Registration Number
- NCT01185808
- Lead Sponsor
- Medical University of South Carolina
- Brief Summary
The purpose of this study is to determine if Vitamin D supplementation improves clinical and immunologic parameters in chronic rhinosinusitis with nasal polyps.
- Detailed 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Chronic sinusitis with polyps
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vitamin D Vitamin D Vitamin D 5,000IU/day for 6 weeks Placebo Vitamin D Placebo for 6 weeks.
- Primary Outcome Measures
Name Time Method Clinical symptom score 6 weeks Symptoms will be graded using Sinonasal Outcomes Test-22.
- Secondary Outcome Measures
Name Time Method Systemic and local immunologic parameters 6 weeks Histologic analysis of sinus immune cells, as well as systemic measurement of immune cells.
Nasal peak inspiratory flow 6 weeks Measurement of maximal nasal peak inspiratory flow
Trial Locations
- Locations (1)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States