CTRI/2017/02/007871招募中不适用
Effect of vitamin D on clinical outcome and biochemical profile in patients with vitamin D-deficient chronic urticaria- a randomized placebo controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- JIPMER
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To study the effect of Vitamin D on clinical outcome by USS(Urticaria Severity Score)
研究概览
简要总结
The purpose of this study is to asess the effect of vitamin D on clinical outcomes and on the changes in levels of 25-hydroxy vitamin D, vitamin D binding protein, hs-CRP ,TGF-β, IL-17, IL-6 and also to study its effect on medication use in Chronic Urticaria patients with vitamin D deficiency. We hypothesize that vitamin D deficient Chronic Urticaria patients receiving vitamin D would have a better clinical outcome and less disease severity when compared to those receiving placebo. Hence vitamin D would improve the quality of life of Chronic Urticaria patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Age and gender matched consenting patients with Chronic urticaria (presence of continuous or recurrent hives with or without angioedema for greater than 6 weeks duration) with vitamin D deficiency (serum vitamin D less than 20 ng per ml) attending the Dermatology Clinic in JIPMER during the study period.
排除标准
- •Patients with •Acute urticaria/physical urticaria/urticarial vasculitis •Hereditary or acquired angioedema •Symptoms of vitamin D deficiency such as musculoskeletal pain, fractures •Patients with hepatic or renal dysfunction •Malignancies/ Infections •Inflammatory cutaneous disorders (psoriasis, lichen planus, pityriasis rubra pilaris, erythroderma, allergic contact dermatitis) •Pregnant and lactating women will be excluded from the study.
结局指标
主要结局
To study the effect of Vitamin D on clinical outcome by USS(Urticaria Severity Score)
时间窗: Baseline, 6 and 12 weeks
次要结局
- To assess the changes in levels of 25-hydroxy vitamin D, vitamin D binding protein, hs-CRP ,TGF-β, IL-17, IL-6.(Baseline and 12 weeks)
研究者
研究点 (1)
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