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

Chronic Rhinosinusitis With Nasal Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02668861
• Other study ID #: FirstTianjunMU
• Status: Recruiting
• Phase: Phase 3
• First received: January 27, 2016
• Last updated: December 3, 2016
• Start date: May 2016
• Est. completion date: May 2017

Study information

• Verified date: December 2016
• Source: The First Affiliated Hospital of Shanxi Medical University
• Contact: Jun Tian
• Phone: 13603514451
• Email: zguotian[@]126.com
• Is FDA regulated: No
• Health authority: China: First Hospital of the Shanxi Medical University
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Rhinosinusitis With Nasal Polyps
• Nasal Polyps
• Sinusitis

Intervention

Drug:
• Vitamin D
Vitamin D 4000IU/day for 8 weeks
• Budesonide Nasal Spray
Budesonide Nasal Spray 128ug/d for 8 week

Other:
• placebo
placebo for 8 weeks

Locations

Country	Name	City	State
China	The First Hospital of Shanxi Medical University	Taiyuan	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Shanxi Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Questionnaire:SNOT-20 evaluates the quality of Life		at 8 weeks after first drug intake	No
Primary	Change of Lund-Kennedy scores		at 8 weeks after first drug intake	No
Secondary	Inflammatory mediators in serum		8 weeks	No
Secondary	Histologic analysis of nasal mucosa		8 weeks	No