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
  Purpose

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


Condition Intervention
Chronic Sinusitis
Biological: Vitamin D

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Clinical symptom score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Symptoms will be graded using Sinonasal Outcomes Test-22.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 30
Study Start Date: October 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D
Vitamin D 5,000IU/day for 6 weeks
Biological: Vitamin D
Vitamin D 5000IU/day for 6 weeks
Other Name: Vitamin D3
Placebo Comparator: Placebo
Placebo for 6 weeks.
Biological: Vitamin D
Vitamin D 5000IU/day for 6 weeks
Other Name: Vitamin D3

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.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01185808

Locations
United States, South Carolina
Medical University of South Carolina Not yet recruiting
Charleston, South Carolina, United States, 29425
Contact: Rodney J Schlosser, MD    843-792-7165    schlossr@musc.edu   
Principal Investigator: Rodney Schlosser, MD         
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Rodney Schlosser, MD Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Rodney J. Schlosser, PI, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01185808     History of Changes
Other Study ID Numbers: Vitamin D in CRSwNP
Study First Received: July 30, 2010
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Medical University of South Carolina:
sinusitis
chronic sinusitis with polyps

Additional relevant MeSH terms:
Nasal Polyps
Sinusitis
Chronic Disease
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Paranasal Sinus Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 16, 2014