Back to resultsEffect of Oral Vitamin D3 on Chronic Rhinosinusitis Treatment in Adults With Lower Vitamin D Levels
Primary Purpose
Chronic Rhinosinusitis With Nasal Polyps
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Vitamin D
Budesonide Nasal Spray
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Rhinosinusitis With Nasal Polyps
Eligibility Criteria
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
Sites / Locations
- The First Hospital of Shanxi Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vitamin D+Budesonide Nasal Spray
placebo+Budesonide Nasal Spray
Arm Description
Vitamin D 4000IU/day for 8 weeks + Budesonide Nasal Spray 128ug/d for 8 week
Placebo for 8 weeks + Budesonide Nasal Spray128ug/d for 8 week
Outcomes
Primary Outcome Measures
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
Questionnaire：SNOT-20 evaluates the quality of Life
Change of Lund-Kennedy scores
Secondary Outcome Measures
Inflammatory mediators in serum
Histologic analysis of nasal mucosa
Full Information
NCT ID
NCT02668861
First Posted
January 27, 2016
Last Updated
December 3, 2016
Sponsor
The First Affiliated Hospital of Shanxi Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02668861
Brief Title
Effect of Oral Vitamin D3 on Chronic Rhinosinusitis Treatment in Adults With Lower Vitamin D Levels
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Shanxi Medical University
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis With Nasal Polyps
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D+Budesonide Nasal Spray
Arm Type
Experimental
Arm Description
Vitamin D 4000IU/day for 8 weeks + Budesonide Nasal Spray 128ug/d for 8 week
Arm Title
placebo+Budesonide Nasal Spray
Arm Type
Placebo Comparator
Arm Description
Placebo for 8 weeks + Budesonide Nasal Spray128ug/d for 8 week
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Intervention Description
Vitamin D 4000IU/day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Budesonide Nasal Spray
Other Intervention Name(s)
Rhinocort Aqua
Intervention Description
Budesonide Nasal Spray 128ug/d for 8 week
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo for 8 weeks
Primary Outcome Measure Information:
Title
VAS evaluation of usual symptoms in patients with CRSwNP
Description
The evaluated symptoms were nasal obstruction, anterior nasal discharge and post-nasal drip, smelling reduction and facial pain
Time Frame
at 8 weeks after first drug intake
Title
Questionnaire：SNOT-20 evaluates the quality of Life
Time Frame
at 8 weeks after first drug intake
Title
Change of Lund-Kennedy scores
Time Frame
at 8 weeks after first drug intake
Secondary Outcome Measure Information:
Title
Inflammatory mediators in serum
Time Frame
8 weeks
Title
Histologic analysis of nasal mucosa
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Tian
Phone
13603514451
Email
zguotian@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Y Fang
Phone
15703410761
Email
m15703410761@163.com
Facility Information:
Facility Name
The First Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huang F Hui
Phone
13934518228
Email
13934518228@163.com
12. IPD Sharing Statement
Learn more about this trial
Effect of Oral Vitamin D3 on Chronic Rhinosinusitis Treatment in Adults With Lower Vitamin D Levels
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