Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps

Study Overview
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Brief Summary
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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
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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.

Official Title
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Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps

Conditions
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Chronic Sinusitis

Intervention / Treatment
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* Biological: Vitamin D


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin D<br>Vitamin D 5,000IU/day for 6 weeks | Biological: Vitamin D<br>* Vitamin D 5000IU/day for 6 weeks<br>* Other names: Vitamin D3;|
| Placebo Comparator: Placebo<br>Placebo for 6 weeks. | Biological: Vitamin D<br>* Vitamin D 5000IU/day for 6 weeks<br>* Other names: Vitamin D3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical symptom score | Symptoms will be graded using Sinonasal Outcomes Test-22. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal peak inspiratory flow | Measurement of maximal nasal peak inspiratory flow | 6 weeks | 
| Systemic and local immunologic parameters | Histologic analysis of sinus immune cells, as well as systemic measurement of immune cells. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sinusitis, chronic sinusitis with polyps