The Impact of Vitamin D Supplementation as an Adjuvant Therapy on Clinical Outcome in Patients With Severe Atopic Dermatitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- difference in the mean Eczema Area and Severity Index (EASI) score at the end of the study
研究概览
简要总结
There is an emergent evidence demonstrating the role of Vitamin D deficiency in eczema. Vitamin D supplementation with standard treatment yielded positive clinical outcomes for children and adolescents with mild and moderate AD; however, the potential benefit of vitamin D in severe cases remains unclear
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, Investigator)
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.diagnosis of severe AD according to Hanifin and Rajka criteria and the Eczema Area and Severity Index (EASI) score
排除标准
- •serious skin disorder other than AD.
- •taking systemic corticosteroids or anti-inflammatory medications, prior vitamin D supplementation
- •receiving oral or topical antibiotics or topical calcineurin inhibitors for at least one week prior to enrollment
- •known gut absorption problem, presence of active skin infection at baseline any known hepatic and/or renal disease.
研究组 & 干预措施
treatment group
vitamin D plus topical 1% hydrocortisone cream twice daily
干预措施: Vitamin D (Drug)
placebo group
placebo plus plus topical 1% hydrocortisone cream twice daily
干预措施: Placebo (Drug)
结局指标
主要结局
difference in the mean Eczema Area and Severity Index (EASI) score at the end of the study
时间窗: 12 weeks
the average percent change in Eczema Area and Severity Index (EASI) score at the end of the study
时间窗: 12 weeks
次要结局
- Difference in proportion of patients with a reduction from baseline of (50 or more up to 75) in Eczema Area and Severity Index (EASI) score(12 weeks)
- Difference in proportion of patients with a reduction from baseline of <50 n Eczema Area and Severity Index (EASI) score(12 weeks)
- Difference in proportion of patients with a reduction from baseline of 75 % in Eczema Area and Severity Index (EASI) score(12 weeks)
研究者
Noha Mansour
Principal Investigator
National Hepatology & Tropical Medicine Research Institute