Effect of Oral Vitamin D3 on Chronic Rhinosinusitis Treatment in Adults With Lower Vitamin D Levels

Study Overview
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Brief Summary
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The purpose of the study is to test the clinical efficacy of oral Vitamin D3 on Wound Healing in patients with Chronic Rhinosinusitis With Nasal Polyposis and Lower Vitamin D Levels After Endonasal Endoscopic Sinus Surgery

Official Title
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Influence of Oral Vitamin D3 on Wound Healing After Endonasal Endoscopic Sinus Surgery for Chronic Rhinosinusitis With Nasal Polyposis and Lower Vitamin D Levels

Conditions
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Chronic Rhinosinusitis With Nasal Polyps

Intervention / Treatment
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* Drug: Vitamin D
* Drug: Budesonide Nasal Spray
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Clinical diagnosis of Chronic Rhinosinusitis with nasal polyps 2. Be 18-60 years old of Chinese people and of either sex，the Han nationality 3. Vitamin D level of less than 30 ng/ml Exclusion Criteria: 1. Women must not be pregnant, breast feeding 2. Chronic oral corticosteroid therapy 3. History of physician-diagnosed nephrolithiasis 4. Chronic diseases（ diabetes，Hypertension，renal insufficiency, severe liver disease） 5.prior surgeries of the paranasal sinuses 6. With an upper respiratory tract infection within 4 weeks of entering the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D+Budesonide Nasal Spray<br>Vitamin D 4000IU/day for 8 weeks + Budesonide Nasal Spray 128ug/d for 8 week | Drug: Vitamin D<br>* Vitamin D 4000IU/day for 8 weeks<br>Drug: Budesonide Nasal Spray<br>* Budesonide Nasal Spray 128ug/d for 8 week<br>* Other names: Rhinocort Aqua;|
| Placebo Comparator: placebo+Budesonide Nasal Spray<br>Placebo for 8 weeks + Budesonide Nasal Spray128ug/d for 8 week | Drug: Budesonide Nasal Spray<br>* Budesonide Nasal Spray 128ug/d for 8 week<br>* Other names: Rhinocort Aqua;Other: placebo<br>* placebo for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS evaluation of usual symptoms in patients with CRSwNP | The evaluated symptoms were nasal obstruction, anterior nasal discharge and post-nasal drip, smelling reduction and facial pain | at 8 weeks after first drug intake | 
| Questionnaire：SNOT-20 evaluates the quality of Life |  | at 8 weeks after first drug intake | 
| Change of Lund-Kennedy scores |  | at 8 weeks after first drug intake | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory mediators in serum |  | 8 weeks | 
| Histologic analysis of nasal mucosa |  | 8 weeks |