Treatment Of Vitamin D Deficiency And Effect On Atopic Dermatitis Severity
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Atopic Dermatitis Severity at the Completion of Treatment
研究概览
简要总结
Atopic dermatitis is a chronic skin disease characterized by a defective skin barrier, inflammation, and increased propensity for skin infections. Vitamin D is a fat-soluble vitamin that is primarily acquired through local production in the skin after ultraviolet light exposure but can also be obtained through natural and supplemental dietary sources. This randomized controlled trial will examine the effects of vitamin D repletion on atopic dermatitis severity in patients with diagnosed deficiency. The investigators hypothesize that pediatric patients with moderate or severe atopic dermatitis and vitamin D deficiency will have improved cutaneous disease after treatment with high dose as compared to standard dose vitamin D.
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
- Single (Investigator)
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Serum 25-hydroxyvitamin D level <20 ng/ml (<50 nmol/L)
- •Diagnosed with atopic dermatitis by a CHW pediatric dermatologist
- •Age 1-18 years old
- •Primary residence in Milwaukee County
- •Moderate and severe atopic dermatitis (Severity Scoring of Atopic Dermatitis [SCORAD] score greater than 15)
- •On clinic protocol treatment for their atopic dermatitis (desonide ointment twice daily for the face and groin, triamcinolone 0.1% ointment twice daily for other areas)
排除标准
- 未提供
研究组 & 干预措施
Standard dose vitamin D
Treatment with cholecalciferol 400 IU daily at home.
干预措施: Vitamin D (Drug)
High dose vitamin D
Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.
干预措施: Vitamin D (Drug)
结局指标
主要结局
Atopic Dermatitis Severity at the Completion of Treatment
时间窗: 6 weeks
SCORAD at the 6 week study visit. The SCORAD (SCORing Atopic Dermatitis) is a clinical tool used to assess the extent and severity of eczema. The SCORAD is scored 0-103, with a higher score indicating more severe atopic dermatitis (worse outcome).
次要结局
- Time to Restart Topical Steroids(6 weeks)
研究者
Yvonne Chiu
Assistant Professor
Medical College of Wisconsin