Role of vitamin D supplementation on symptom score and quality of life in patients with chronic urticaria.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- KIMS
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare the reduction in urticaria activity score (UAS7) following the vitamin D supplementation along with standard treatment in comparison to only standard treatment in patients with chronic urticaria.
研究概览
简要总结
A study to know the reduction in urticaria activity score(UAS7) following the administration of vitamin D along with standard treatmentin comparison to only standard treatment at the end of 12 weeks and also the effect ofVitamin D supplementation on the reduction in medication dosage and quality oflife scores in Chronic urticaria.
Vitamin D is an immunoregulatory hormone and represents a relatively safe andinexpensive supplement, with clinical evidence to support its consideration anduse as supplement for patients with CU. Given the above, there is an obviousneed for clinical studies to understand the clinical benefit of vitamin D. Thisis of particular relevance because the Indian population is reported to have awidespread prevalence of varying degrees (50–90%) of vitamin D deficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age :20-60 years.
- •Sex : Both gender.
- •3.Chronic spontaneous urticaria patients having recurrent wheals occurring at least 3 times per week for more than 6 weeks within the past year.
排除标准
- •EXCLUSION CRITERIA : 1.Acute urticaria patients.
- •Physical urticaria patients 3.Urticarial vasculitis patients.
- •4.Hereditory or acquired angioedema patients.
- •Those who have taken vitamin D supplements .
- •6.Pregnant and lactating females.
结局指标
主要结局
To compare the reduction in urticaria activity score (UAS7) following the vitamin D supplementation along with standard treatment in comparison to only standard treatment in patients with chronic urticaria.
时间窗: 12 weeks
次要结局
- The secondary outcomes include the effect of Vitamin D supplementation on the reduction in medication dosage and quality of life scores in CU.(12 weeks)