Impact of Vitamin D Supplementation on Clinical Severity and Immunologic Tolerance of Pediatric Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Change in SCORAD index
研究概览
简要总结
The purpose of this study is to determine whether oral vitamin D supplementation improves the clinical severity of atopic dermatitis in children. In addition, this study plans to evaluate the effects of vitamin D supplementation on several key aspects of the immune system of children with atopic dermatitis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Atopic dermatitis diagnosed according to Hanifin and Rajka criteria
- •Age 2 - 17 years
- •SCORAD 10 - 103
排除标准
- •Active skin infection
- •History of underlying illness causing immunosuppression within the past 2 years
- •Immunosuppressors taken within the past month
- •Parathyroid disease
- •Sarcoidosis
- •Acute or chronic renal disease
- •Hyper or hypocalcemia
- •Thyroid disease
- •Osteomalacia or Paget's disease of bone
- •Malabsorption
- •Use of VD supplements (> 400 IU daily) or fish oil supplements in the past month
- •Treatment for known VD deficiency in the last 6 months
- •Treatment with moderate or high potency topical corticosteroids, oral or topical antibiotics, oral antivirals, immune enhancers, or topical calcineurin inhibitors in the past 7 days
- •Phototherapy in the past month
- •Autoimmune disease or immunodeficiency
- •Planned trip to sunny climate during the 6-week study.
研究组 & 干预措施
Placebo
Subjects in the placebo arm will receive weekly placebo oral suspension during 6 weeks.
干预措施: Placebo (Dietary Supplement)
Vitamin D3 supplementation
Subjects in the experimental arm will receive weekly vitamin D3 doses in oral suspension during 6 weeks. Weekly dose varies according to age group: VD3 8000 IU between ages 2-5.9 years, VD3 12000 IU between ages 6-11.9 years, VD3 16000 IU between ages 12-17.9 years.
干预措施: Vitamin D3 (Dietary Supplement)
结局指标
主要结局
Change in SCORAD index
时间窗: baseline and 6 weeks
Change in Scoring Atopic Dermatitis (SCORAD) index after 6 weeks of vitamin D3 (VD3) supplementation or placebo in children with atopic dermatitis.
次要结局
- Change in dendritic cell-mediated tolerance and regulatory T cells(baseline and 6 weeks)
- Changes in Th2 immunity(baseline and 6 weeks)
- Vitamin D receptor single nucleotide polymorphisms(baseline and 6 weeks)
- Change in epidermal protein expression(6 weeks)
- Effect of VD3 supplementation on immunity to Staphylococcus aureus(baseline and 6 weeks)