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

History of Changes

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:

MedlinePlus related topics: Sinusitis Vitamin D

Drug Information available for: Vitamin D

U.S. FDA Resources

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:

Sinusitis
Nasal Polyps
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 May 23, 2013

To Top