Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 2013

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.

Interventions

  • Biological: Vitamin D
    • Vitamin D 5000IU/day for 6 weeks

Arms, Groups and Cohorts

  • Active Comparator: Vitamin D
    • Vitamin D 5,000IU/day for 6 weeks
  • Placebo Comparator: Placebo
    • Placebo for 6 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Clinical symptom score
    • Time Frame: 6 weeks
    • Symptoms will be graded using Sinonasal Outcomes Test-22.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 14 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical University of South Carolina
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rodney J. Schlosser, PI – Medical University of South Carolina
  • Overall Official(s)
    • Rodney Schlosser, MD, Principal Investigator, Medical University of South Carolina

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