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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2010 by Medical University of South Carolina.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT01185808

First received: July 30, 2010

Last updated: August 25, 2010

Last verified: August 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

July 30, 2010

Last Updated Date

August 25, 2010

Start Date ^ICMJE

October 2010

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Clinical symptom score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Symptoms will be graded using Sinonasal Outcomes Test-22.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01185808 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Arm (s)

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

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2012

Estimated Primary Completion Date

January 2012 (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.

Gender

Both

Ages

14 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01185808

Other Study ID Numbers ^ICMJE

Vitamin D in CRSwNP

Has Data Monitoring Committee

Responsible Party

Rodney J. Schlosser, MD, 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

Information Provided By

Medical University of South Carolina

Verification Date

August 2010

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

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