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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2013 by Rodney J. Schlosser, Medical University of South Carolina.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01185808
First Posted: August 20, 2010
Last Update Posted: May 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rodney J. Schlosser, Medical University of South Carolina
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Rodney J. Schlosser, Medical University of South Carolina:

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


Secondary Outcome 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.


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

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: July 30, 2010
First Posted: August 20, 2010
Last Update Posted: May 22, 2013
Last Verified: May 2013

Keywords provided by Rodney J. Schlosser, Medical University of South Carolina:
sinusitis
chronic sinusitis with polyps

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


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