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

Phase 3

• Conditions: Chronic Rhinosinusitis With Nasal Polyps
• Interventions: Drug: Vitamin D; Drug: Budesonide Nasal Spray; Other: placebo

• Registration Number: NCT02668861
• Lead Sponsor: The First Affiliated Hospital of Shanxi Medical University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-27
• Study First Submitted QC: 2016-01-27
• Study First Posted: 2016-01-29
• Study Start: 2016-05
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-03
• Last Update Posted: 2016-12-06
• Primary Completion: 2017-05
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin D+Budesonide Nasal Spray	Budesonide Nasal Spray	Vitamin D 4000IU/day for 8 weeks + Budesonide Nasal Spray 128ug/d for 8 week
Vitamin D+Budesonide Nasal Spray	Vitamin D	Vitamin D 4000IU/day for 8 weeks + Budesonide Nasal Spray 128ug/d for 8 week
placebo+Budesonide Nasal Spray	Budesonide Nasal Spray	Placebo for 8 weeks + Budesonide Nasal Spray128ug/d for 8 week
placebo+Budesonide Nasal Spray	placebo	Placebo for 8 weeks + Budesonide Nasal Spray128ug/d for 8 week

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Inflammatory mediators in serum	8 weeks
Histologic analysis of nasal mucosa	8 weeks

Trial Locations

Locations (1)

The First Hospital of Shanxi Medical University; 🇨🇳 Taiyuan, Shanxi, China