Evaluation of the Effect of Vitamin K2 on the Clinical Outcome of Pediatric Patients With Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- to evaluate the impact of vitamin K2 on the severity of atopic dermatitis, as assessed by the SCORAD score
研究概览
简要总结
investigate the effectiveness and safety of adding vitamin K2 at a dose of 45 mg/day for 12 weeks to conventional therapy for paediatric patients with moderate to severe atopic dermatitis according to SCORAD score
详细描述
This was a multicentre, prospective, blind randomized. patients are randomized to either receive their conventional therapy alone or by adding vitamin k2 for 12 weeks. The primary outcome was to evaluate the impact of vitamin K2 on the severity of atopic dermatitis, as assessed by the SCORAD score at 12 weeks compared to baseline.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 6-12 years
- •moderate to severe AD according to SCORAD score
排除标准
- •other cutaneous allergic diseases (urticaria, angioedema, anaphylaxis, contact dermatitis).
- •primary immunodeficiency (PID) with cutaneous allergic manifestations.
研究组 & 干预措施
Patients received placebo orally once daily for 12 weeks in addition to their Conv
Patients received placebo orally once daily for 12 weeks in addition to their Conv
干预措施: Placebo (Other)
vit k2 group
receive oral vitamin k2 45mg once daily for 12 weeks in addition to their conventional treatment
干预措施: vit k2 (Dietary Supplement)
结局指标
主要结局
to evaluate the impact of vitamin K2 on the severity of atopic dermatitis, as assessed by the SCORAD score
时间窗: at baseline and after 3months
次要结局
- Janus kinase (JAK)(Measured at baseline and after three months)
- Serum total IgE(At baseline and after three months)
- IL-13(at baseline and after three months)
- lipid profile(at baseline and after three months)
- Examination of the skin for eczema distribution, extent and intensity and Complete systemic examination for different forms of allergic disorder.(3months)
研究者
Aya Elsayed
Dr Aya elsayed
October 6 University