Effect of Oral Vitamin D3 on Chronic Rhinosinusitis Treatment in Adults With Lower Vitamin D Levels
Influence of Oral Vitamin D3 on Wound Healing After Endonasal Endoscopic Sinus Surgery for Chronic Rhinosinusitis With Nasal Polyposis and Lower Vitamin D Levels
1 other identifier
interventional
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2016
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2016
CompletedFirst Posted
Study publicly available on registry
January 29, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedDecember 6, 2016
December 1, 2016
1 year
January 27, 2016
December 3, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
Inflammatory mediators in serum
8 weeks
Histologic analysis of nasal mucosa
8 weeks
Study Arms (2)
Vitamin D+Budesonide Nasal Spray
EXPERIMENTALVitamin D 4000IU/day for 8 weeks + Budesonide Nasal Spray 128ug/d for 8 week
placebo+Budesonide Nasal Spray
PLACEBO COMPARATORPlacebo for 8 weeks + Budesonide Nasal Spray128ug/d for 8 week
Interventions
Budesonide Nasal Spray 128ug/d for 8 week
Eligibility Criteria
You may qualify if:
- \. 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
You may not qualify if:
- \. 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 27, 2016
First Posted
January 29, 2016
Study Start
May 1, 2016
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
December 6, 2016
Record last verified: 2016-12