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临床试验/NCT01185808
NCT01185808撤回不适用

Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps

Medical University of South Carolina2 个研究点 分布在 1 个国家开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Clinical symptom score

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic sinusitis with polyps

排除标准

  • 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.

结局指标

主要结局

Clinical symptom score

时间窗: 6 weeks

Symptoms will be graded using Sinonasal Outcomes Test-22.

次要结局

  • Systemic and local immunologic parameters(6 weeks)
  • Nasal peak inspiratory flow(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rodney J. Schlosser

PI

Medical University of South Carolina

研究点 (2)

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