Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01185808

Acronym

VDinCRS

Enrollment

Registered

2010-08-20

Start date

2013-10-31

Completion date

2013-10-31

Last updated

2018-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Sinusitis

Keywords

sinusitis, chronic sinusitis with polyps

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.

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.

Interventions

BIOLOGICALVitamin D

Vitamin D 5000IU/day for 6 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

14 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Clinical symptom score	6 weeks	Symptoms will be graded using Sinonasal Outcomes Test-22.

Secondary

Measure	Time frame	Description
Nasal peak inspiratory flow	6 weeks	Measurement of maximal nasal peak inspiratory flow
Systemic and local immunologic parameters	6 weeks	Histologic analysis of sinus immune cells, as well as systemic measurement of immune cells.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026