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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01185808
Recruitment Status : Withdrawn
First Posted : August 20, 2010
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Rodney J. Schlosser, Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE July 30, 2010
First Posted Date  ICMJE August 20, 2010
Last Update Posted Date May 1, 2018
Study Start Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2010)
Clinical symptom score [ Time Frame: 6 weeks ]
Symptoms will be graded using Sinonasal Outcomes Test-22.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2010)
  • Nasal peak inspiratory flow [ Time Frame: 6 weeks ]
    Measurement of maximal nasal peak inspiratory flow
  • Systemic and local immunologic parameters [ Time Frame: 6 weeks ]
    Histologic analysis of sinus immune cells, as well as systemic measurement of immune cells.
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 Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps
Official Title  ICMJE Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Sinusitis
Intervention  ICMJE Biological: Vitamin D
Vitamin D 5000IU/day for 6 weeks
Other Name: Vitamin D3
Study Arms  ICMJE
  • 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
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 27, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 19, 2010)
30
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01185808
Other Study ID Numbers  ICMJE Vitamin D in CRSwNP
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rodney J. Schlosser, Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rodney Schlosser, MD Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date April 2018

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