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

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.
 
ClinicalTrials.gov Identifier: NCT01185808
Recruitment Status : Withdrawn
First Posted : August 20, 2010
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Rodney J. Schlosser, Medical University of South Carolina

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Sinusitis Biological: Vitamin D Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps
Study Start Date : October 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis Vitamin D

Arms and Interventions
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Arm Intervention/treatment
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


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


Secondary Outcome Measures :
  1. Nasal peak inspiratory flow [ Time Frame: 6 weeks ]
    Measurement of maximal nasal peak inspiratory flow

  2. Systemic and local immunologic parameters [ Time Frame: 6 weeks ]
    Histologic analysis of sinus immune cells, as well as systemic measurement of immune cells.


Eligibility Criteria
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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
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
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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
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Rodney Schlosser, MD Medical University of South Carolina
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Rodney J. Schlosser, PI, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01185808    
Other Study ID Numbers: Vitamin D in CRSwNP
First Posted: August 20, 2010    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Keywords provided by Rodney J. Schlosser, Medical University of South Carolina:
sinusitis
chronic sinusitis with polyps
Additional relevant MeSH terms:
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Sinusitis
Nasal Polyps
Polyps
Pathological Conditions, Anatomical
Respiratory Tract Infections
Infections
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
 Otorhinolaryngologic Diseases
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents