Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps (VDinCRS)

This study is not yet open for participant recruitment.
Verified May 2013 by Medical University of South Carolina
Sponsor:
Information provided by (Responsible Party):
Rodney J. Schlosser, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01185808
First received: July 30, 2010
Last updated: May 20, 2013
Last verified: May 2013

July 30, 2010
May 20, 2013
October 2013
January 2015   (final data collection date for primary outcome measure)
Clinical symptom score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Symptoms will be graded using Sinonasal Outcomes Test-22.
Same as current
Complete list of historical versions of study NCT01185808 on ClinicalTrials.gov Archive Site
  • Nasal peak inspiratory flow [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Measurement of maximal nasal peak inspiratory flow
  • Systemic and local immunologic parameters [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Histologic analysis of sinus immune cells, as well as systemic measurement of immune cells.
Same as current
Not Provided
Not Provided
 
Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps
Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps

The purpose of this study is to determine if Vitamin D supplementation improves clinical and immunologic parameters in chronic rhinosinusitis with nasal polyps.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Sinusitis
Biological: Vitamin D
Vitamin D 5000IU/day for 6 weeks
Other Name: Vitamin D3
  • Active Comparator: Vitamin D
    Vitamin D 5,000IU/day for 6 weeks
    Intervention: Biological: Vitamin D
  • Placebo Comparator: Placebo
    Placebo for 6 weeks.
    Intervention: Biological: Vitamin D
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
January 2015
January 2015   (final data collection date for primary outcome measure)

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.
Both
14 Years and older
No
Not Provided
United States
 
NCT01185808
Vitamin D in CRSwNP
No
Rodney J. Schlosser, Medical University of South Carolina
Medical University of South Carolina
Not Provided
Principal Investigator: Rodney Schlosser, MD Medical University of South Carolina
Medical University of South Carolina
May 2013

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