NCT02873364Unknown3 期
High Dose Vitamin D Supplementation in Treatment of Chronic Spontaneous Urticaria
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Urticaria symptom severity questionnaire after 1 week
研究概览
简要总结
Chronic spontaneous urticaria is an inflammatory disease which is characterized with intermittent or daily urticaria. This diseases lasts for more than 6 weeks. Several recent studies have suggested a role for vitamin D in modulation of immune system and pathogenesis of chronic urticaria.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Uriticaria or angioedema daily or more than 3 days a weeks for at least 6 weeks
排除标准
- •Physical urticaria aquired or hereditary angioedema Calcium level > 10.3 mg/dl Glomerular filtration rate <50 Sarcoidosis Primary hyperparathyroidism Granulomatous diseases Malignancies Pregnancy Lactation
研究组 & 干预措施
Vitamin D3 (Low dose)
Active Comparator
Daily 600 unites of vitamin D + Cetirizine 10mg twice a day
干预措施: Vitamin D3 (Low dose) (Drug)
Vitamin D3 (High dose)
Experimental
Daily 4000 unites vitamin D + Cetirizine 10mg twice a day
干预措施: Vitamin D3 (High dose) (Drug)
结局指标
主要结局
Urticaria symptom severity questionnaire after 1 week
时间窗: 1 weeks
Urticaria Symptom Severity ranging from 0 to 93
次要结局
- Urticaria symptom severity questionnaire after 6 week(6 weeks)
- Urticaria symptom severity questionnaire after 12 week(12 weeks)
研究者
Keramatallah Jahanshahi
Resident of internal medicine
Shiraz University of Medical Sciences
研究点 (1)
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