Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2013-10-31

Brief Summary

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The purpose of this study is to determine if Vitamin D supplementation improves clinical and immunologic parameters in chronic rhinosinusitis with nasal polyps.

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Detailed Description

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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.

Conditions

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Chronic Sinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vitamin D

Vitamin D 5,000IU/day for 6 weeks

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type BIOLOGICAL

Vitamin D 5000IU/day for 6 weeks

Placebo

Placebo for 6 weeks.

Group Type PLACEBO_COMPARATOR

Vitamin D

Intervention Type BIOLOGICAL

Vitamin D 5000IU/day for 6 weeks

Interventions

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Vitamin D

Vitamin D 5000IU/day for 6 weeks

Intervention Type BIOLOGICAL

Other Intervention Names

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Vitamin D3

Eligibility Criteria

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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.

Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No