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

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ClinicalTrials.gov Identifier: NCT02668861
Recruitment Status : Unknown
Verified December 2016 by Jun Tian, The First Affiliated Hospital of Shanxi Medical University.
Recruitment status was:  Recruiting
First Posted : January 29, 2016
Last Update Posted : December 6, 2016
Sponsor:
Information provided by (Responsible Party):
Jun Tian, The First Affiliated Hospital of Shanxi Medical University

Tracking Information
First Submitted Date  ICMJE January 27, 2016
First Posted Date  ICMJE January 29, 2016
Last Update Posted Date December 6, 2016
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2016)
  • VAS evaluation of usual symptoms in patients with CRSwNP [ Time Frame: 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 [ Time Frame: at 8 weeks after first drug intake ]
  • Change of Lund-Kennedy scores [ Time Frame: at 8 weeks after first drug intake ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 27, 2016)
  • Change of subjective symptoms visual analog scores(VAS) [ Time Frame: at 8 weeks after first drug intake ]
  • Clinical symptom score (Symptoms will be graded using Snot-20) [ Time Frame: at 8 weeks after first drug intake ]
  • Change of Lund-Kennedy scores [ Time Frame: at 8 weeks after first drug intake ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2016)
  • Inflammatory mediators in serum [ Time Frame: 8 weeks ]
  • Histologic analysis of nasal mucosa [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Oral Vitamin D3 on Chronic Rhinosinusitis Treatment in Adults With Lower Vitamin D Levels
Official Title  ICMJE Influence of Oral Vitamin D3 on Wound Healing After Endonasal Endoscopic Sinus Surgery for Chronic Rhinosinusitis With Nasal Polyposis and Lower Vitamin D Levels
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Rhinosinusitis With Nasal Polyps
Intervention  ICMJE
  • Drug: Vitamin D
    Vitamin D 4000IU/day for 8 weeks
  • Drug: Budesonide Nasal Spray
    Budesonide Nasal Spray 128ug/d for 8 week
    Other Name: Rhinocort Aqua
  • Other: placebo
    placebo for 8 weeks
Study Arms  ICMJE
  • Experimental: Vitamin D+Budesonide Nasal Spray
    Vitamin D 4000IU/day for 8 weeks + Budesonide Nasal Spray 128ug/d for 8 week
    Interventions:
    • Drug: Vitamin D
    • Drug: Budesonide Nasal Spray
  • Placebo Comparator: placebo+Budesonide Nasal Spray
    Placebo for 8 weeks + Budesonide Nasal Spray128ug/d for 8 week
    Interventions:
    • Drug: Budesonide Nasal Spray
    • Other: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 27, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2017
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02668861
Other Study ID Numbers  ICMJE FirstTianjunMU
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jun Tian, The First Affiliated Hospital of Shanxi Medical University
Study Sponsor  ICMJE The First Affiliated Hospital of Shanxi Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The First Affiliated Hospital of Shanxi Medical University
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP