- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01185808
Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps (VDinCRS)
Study Overview
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
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Vitamin D
Vitamin D 5,000IU/day for 6 weeks
|
Vitamin D 5000IU/day for 6 weeks
Other Names:
|
Placebo Comparator: Placebo
Placebo for 6 weeks.
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Vitamin D 5000IU/day for 6 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical symptom score
Time Frame: 6 weeks
|
Symptoms will be graded using Sinonasal Outcomes Test-22.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nasal peak inspiratory flow
Time Frame: 6 weeks
|
Measurement of maximal nasal peak inspiratory flow
|
6 weeks
|
Systemic and local immunologic parameters
Time Frame: 6 weeks
|
Histologic analysis of sinus immune cells, as well as systemic measurement of immune cells.
|
6 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rodney Schlosser, MD, Medical University of South Carolina
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Otorhinolaryngologic Diseases
- Pathological Conditions, Anatomical
- Paranasal Sinus Diseases
- Nose Diseases
- Polyps
- Sinusitis
- Nasal Polyps
- Physiological Effects of Drugs
- Micronutrients
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Cholecalciferol
- Vitamins
- Ergocalciferols
Other Study ID Numbers
- Vitamin D in CRSwNP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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