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

This study is currently recruiting participants.
See Contacts and Locations
Verified December 2016 by Jun Tian, The First Affiliated Hospital of Shanxi Medical University
Sponsor:
Information provided by (Responsible Party):
Jun Tian, The First Affiliated Hospital of Shanxi Medical University
ClinicalTrials.gov Identifier:
NCT02668861
First received: January 27, 2016
Last updated: December 3, 2016
Last verified: December 2016
  Purpose
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

Condition Intervention Phase
Chronic Rhinosinusitis With Nasal Polyps Drug: Vitamin D Drug: Budesonide Nasal Spray Other: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Jun Tian, The First Affiliated Hospital of Shanxi Medical University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Inflammatory mediators in serum [ Time Frame: 8 weeks ]
  • Histologic analysis of nasal mucosa [ Time Frame: 8 weeks ]

Estimated Enrollment: 40
Study Start Date: May 2016
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D+Budesonide Nasal Spray
Vitamin D 4000IU/day for 8 weeks + Budesonide Nasal Spray 128ug/d for 8 week
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
Placebo Comparator: placebo+Budesonide Nasal Spray
Placebo for 8 weeks + Budesonide Nasal Spray128ug/d for 8 week
Drug: Budesonide Nasal Spray
Budesonide Nasal Spray 128ug/d for 8 week
Other Name: Rhinocort Aqua
Other: placebo
placebo for 8 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02668861

Contacts
Contact: Jun Tian 13603514451 zguotian@126.com
Contact: Ying Y Fang 15703410761 m15703410761@163.com

Locations
China, Shanxi
The First Hospital of Shanxi Medical University Recruiting
Taiyuan, Shanxi, China
Contact: Huang F Hui    13934518228    13934518228@163.com   
Sponsors and Collaborators
The First Affiliated Hospital of Shanxi Medical University
  More Information

Responsible Party: Jun Tian, Associate Professor, The First Affiliated Hospital of Shanxi Medical University
ClinicalTrials.gov Identifier: NCT02668861     History of Changes
Other Study ID Numbers: FirstTianjunMU
Study First Received: January 27, 2016
Last Updated: December 3, 2016

Additional relevant MeSH terms:
Sinusitis
Nasal Polyps
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Budesonide
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on June 23, 2017