Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps (VDinCRS)
Primary Purpose
Chronic Sinusitis
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Sinusitis focused on measuring sinusitis, chronic sinusitis with polyps
Eligibility Criteria
Inclusion Criteria:
- Chronic sinusitis with polyps
Exclusion Criteria:
- Use of systemic steroids, or other immunmodulatory agents in preceding monthS, other immunologic, renal, gastrointestinal, endocrine or skeletal disorder (rheumatoid arthritis, immunodeficiency, cystic fibrosis, ciliary dyskinesia, malabsorption, etc.)
- Pregnancy or age less than 14 years.
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Vitamin D
Placebo
Arm Description
Vitamin D 5,000IU/day for 6 weeks
Placebo for 6 weeks.
Outcomes
Primary Outcome Measures
Clinical symptom score
Symptoms will be graded using Sinonasal Outcomes Test-22.
Secondary Outcome Measures
Nasal peak inspiratory flow
Measurement of maximal nasal peak inspiratory flow
Systemic and local immunologic parameters
Histologic analysis of sinus immune cells, as well as systemic measurement of immune cells.
Full Information
NCT ID
NCT01185808
First Posted
July 30, 2010
Last Updated
April 27, 2018
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT01185808
Brief Title
Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps
Acronym
VDinCRS
Official Title
Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Withdrawn
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if Vitamin D supplementation improves clinical and immunologic parameters in chronic rhinosinusitis with nasal polyps.
Detailed Description
Introductory Statement: Our laboratory has found that patients with chronic rhinosinusitis with nasal polyps (CRSwNP) have insufficient levels of vitamin D3. This is a proposal to conduct a placebo controlled trial on the use of vitamin D3 (5,000IU/day for 6 weeks) to determine clinical and immunologic outcomes in these patients.
General Investigational Plan: We routinely examine vitamin D levels in all patients with CRSwNP. Those that are insufficient (less than 32 ng/ml) and have agreed to undergo sinus surgery will be randomized to placebo or vitamin D3 supplementation (5,000IU/day) for 6 weeks prior to surgery. Blood will be drawn pre- and post-supplementation to examine systemic immune parameters such as dendritic cell and T cell expression and cytokine levels. Sinus tissue will be collected at the time of surgery to analyze local immune parameters (dendritic cell, T cell and cytokine levels) between supplemented and placebo groups. Clinical outcomes will be analyzed using quality of life questionnaires, endoscopic grading and nasal peak inspiratory flow pre- and post- supplementation. IRB approval for this research project is pending.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis
Keywords
sinusitis, chronic sinusitis with polyps
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D
Arm Type
Active Comparator
Arm Description
Vitamin D 5,000IU/day for 6 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for 6 weeks.
Intervention Type
Biological
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
Vitamin D3
Intervention Description
Vitamin D 5000IU/day for 6 weeks
Primary Outcome Measure Information:
Title
Clinical symptom score
Description
Symptoms will be graded using Sinonasal Outcomes Test-22.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Nasal peak inspiratory flow
Description
Measurement of maximal nasal peak inspiratory flow
Time Frame
6 weeks
Title
Systemic and local immunologic parameters
Description
Histologic analysis of sinus immune cells, as well as systemic measurement of immune cells.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic sinusitis with polyps
Exclusion Criteria:
Use of systemic steroids, or other immunmodulatory agents in preceding monthS, other immunologic, renal, gastrointestinal, endocrine or skeletal disorder (rheumatoid arthritis, immunodeficiency, cystic fibrosis, ciliary dyskinesia, malabsorption, etc.)
Pregnancy or age less than 14 years.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodney Schlosser, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps
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