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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on August 28, 2014