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

December 3, 2016 updated by: Jun Tian, The First Affiliated Hospital of Shanxi Medical University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanxi
      • Taiyuan, Shanxi, China
        • Recruiting
        • The First Hospital of Shanxi Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Rhinocort Aqua
Other: placebo
placebo for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 8 weeks after first drug intake
Questionnaire：SNOT-20 evaluates the quality of Life
Time Frame: at 8 weeks after first drug intake
at 8 weeks after first drug intake
Change of Lund-Kennedy scores
Time Frame: at 8 weeks after first drug intake
at 8 weeks after first drug intake

Secondary Outcome Measures

Outcome Measure
Time Frame
Inflammatory mediators in serum
Time Frame: 8 weeks
8 weeks
Histologic analysis of nasal mucosa
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Shanxi Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

January 27, 2016

First Submitted That Met QC Criteria

January 27, 2016

First Posted (Estimate)

January 29, 2016

Study Record Updates

Last Update Posted (Estimate)

December 6, 2016

Last Update Submitted That Met QC Criteria

December 3, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FirstTianjunMU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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