Chronic Rhinosinusitis With Nasal Polyps
Conditions
Brief summary
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
Interventions
DRUGVitamin D
Vitamin D 4000IU/day for 8 weeks
Budesonide Nasal Spray 128ug/d for 8 week
OTHERplacebo
placebo for 8 weeks
Sponsors
The First Affiliated Hospital of Shanxi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS evaluation of usual symptoms in patients with CRSwNP | at 8 weeks after first drug intake | The evaluated symptoms were nasal obstruction, anterior nasal discharge and post-nasal drip, smelling reduction and facial pain |
| 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
| Measure | Time frame |
|---|---|
| Inflammatory mediators in serum | 8 weeks |
| Histologic analysis of nasal mucosa | 8 weeks |
Countries
China
Contacts
Primary ContactJun Tian
Backup ContactYing Y Fang
Outcome results
None listed