Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps

Chronic Sinusitis Clinical Trial

— VDinCRS  

Official title:

Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01185808
• Other study ID #: Vitamin D in CRSwNP
• Status: Withdrawn
• Phase: N/A
• Start date: October 2013
• Est. completion date: October 2013

Study information

• Verified date: April 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Sinusitis
• Nasal Polyps
• Sinusitis

Intervention

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

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical symptom score	Symptoms will be graded using Sinonasal Outcomes Test-22.	6 weeks
Secondary	Nasal peak inspiratory flow	Measurement of maximal nasal peak inspiratory flow	6 weeks
Secondary	Systemic and local immunologic parameters	Histologic analysis of sinus immune cells, as well as systemic measurement of immune cells.	6 weeks