Effect of Vitamin d Deficiency in Chronic Rhinosinusitis With Nasal Polyposis: Clinical, Laboratory & Immunohistochemical Study
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- patient complaint
研究概览
简要总结
Aim of the work
- To determine if chronic rhinosinusitis with nasal polyps' (CRSwNP) populations are vitamin D deficient.
- To determine the possible anti-inflammatory effect of vitamin D supplementation (clinically & histologically). & investigate its relation to immunohistochemical tissue expression of basic fibroblast growth factor
详细描述
Patients & methods
Study groups:
Fifty patients with the clinical diagnosis of chronic rhinosinusitis with nasal Polyposis (CRSwNP) resistant to medical treatment at Otorhinolaryngology outpatient clinic, Ain Shams University hospitals. Group I : twenty five patients will receive vitamin D supplementation, while group II won't receive vitamin D supplementation.
Inclusion criteria:
Patients (18-60) years of age with clinical diagnosis of chronic rhinosinusitis with nasal Polyposis (CRSwNP) resistant to medical treatment at Otorhinolaryngology outpatient clinic, Ain Shams University hospital.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
all will be masked
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
- •Patients (18-60) years of age with clinical diagnosis of chronic rhinosinusitis with nasal Polyposis (CRSwNP) at Otorhinolaryngology outpatient clinic, Ain Shams University hospital.
排除标准
- •• Pregnant and lactating females.
- •Patients taking multivitamins containing vitamin D for at least six months.
- •Immune deficiency or suppression.
- •Ciliary motility disorders.
- •Wegner's granulomatosis and other granulomatous diseases.
- •Sino-nasal malignancy.
研究组 & 干预措施
group I
twenty-five patients with the clinical diagnosis of chronic rhinosinusitis with nasal Polyposis will receive vitamin D supplementation
干预措施: vitamin D supplementation (Drug)
group II
twenty-five patients with the clinical diagnosis of chronic rhinosinusitis with nasal Polyposis will NOT receive vitamin D supplementation
干预措施: usual therapy for nasal polyposis (Drug)
结局指标
主要结局
patient complaint
时间窗: 6 weeks
by SNOT-22 , Sino-nasal Outcome Test , completion of the SNOT-22 prior to and following Vitamin D supplementation . Each subject completed the SNOT-22 during a clinic visit by answering all questions based on a 0-5 scale, where 0 defines no problems with the given symptom and 5 defines maximal problems
examintaion
时间窗: 6 weeks
Lund \& Kennedy endoscopic appearance score, examination will be done before and after vitamin D supplementation , with 0 means absent finding and 2 means worst finding
histopathology
时间窗: 6 weeks
immunohistochemitsry for fibroblast growth factor
次要结局
未报告次要终点
研究者
Mohammad Salah Mohammad Mahmoud
Doctor
Ain Shams University