Influence of Oral Vitamin D3 on Wound Healing After Endonasal Endoscopic Sinus Surgery for Chronic Rhinosinusitis With Nasal Polyposis and Lower Vitamin D Levels
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- VAS evaluation of usual symptoms in patients with CRSwNP
研究概览
简要总结
The purpose of the study is to test the clinical efficacy of oral Vitamin D3 on Wound Healing in patients with Chronic Rhinosinusitis With Nasal Polyposis and Lower Vitamin D Levels After Endonasal Endoscopic Sinus Surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Chronic Rhinosinusitis with nasal polyps
- •Be 18-60 years old of Chinese people and of either sex，the Han nationality
- •Vitamin D level of less than 30 ng/ml
排除标准
- •Women must not be pregnant, breast feeding
- •Chronic oral corticosteroid therapy
- •History of physician-diagnosed nephrolithiasis
- •Chronic diseases（ diabetes，Hypertension，renal insufficiency, severe liver disease） 5.prior surgeries of the paranasal sinuses
- •With an upper respiratory tract infection within 4 weeks of entering the study
研究组 & 干预措施
Vitamin D+Budesonide Nasal Spray
Vitamin D 4000IU/day for 8 weeks + Budesonide Nasal Spray 128ug/d for 8 week
干预措施: Vitamin D (Drug)
Vitamin D+Budesonide Nasal Spray
Vitamin D 4000IU/day for 8 weeks + Budesonide Nasal Spray 128ug/d for 8 week
干预措施: Budesonide Nasal Spray (Drug)
placebo+Budesonide Nasal Spray
Placebo for 8 weeks + Budesonide Nasal Spray128ug/d for 8 week
干预措施: Budesonide Nasal Spray (Drug)
placebo+Budesonide Nasal Spray
Placebo for 8 weeks + Budesonide Nasal Spray128ug/d for 8 week
干预措施: placebo (Other)
结局指标
主要结局
VAS evaluation of usual symptoms in patients with CRSwNP
时间窗: at 8 weeks after first drug intake
The evaluated symptoms were nasal obstruction, anterior nasal discharge and post-nasal drip, smelling reduction and facial pain
Questionnaire：SNOT-20 evaluates the quality of Life
时间窗: at 8 weeks after first drug intake
Change of Lund-Kennedy scores
时间窗: at 8 weeks after first drug intake
次要结局
- Inflammatory mediators in serum(8 weeks)
- Histologic analysis of nasal mucosa(8 weeks)
研究者
Jun Tian
Associate Professor
The First Affiliated Hospital of Shanxi Medical University