NCT00879424已完成不适用
Randomized Trial of Vitamin D Supplementation in Winter-related, Childhood Atopic Dermatitis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Investigator Global Assessment (IGA)
研究概览
简要总结
The goal of this clinical trial is to investigate the therapeutic role of vitamin D supplementation in a subset of patients with atopic dermatitis (AD): children with disease onset or worsening in the winter. The investigators hypothesis is that (1) vitamin D supplementation in patients with either wintertime onset or exacerbation of AD will improve Eczema Area and Severity Index (EASI) scores, and (2) vitamin D supplementation will improve the Investigator's Global Assessment.
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
- •Age 2-17 years
- •AD rated 10-72 by EASI scale
- •Wintertime onset or exacerbation of AD
排除标准
- •Active skin infection
- •History of summertime onset or exacerbation of AD
- •History of underlying illness causing immunosuppression within the past 2 years (eg. hematologic malignancies)
- •Medications causing iatrogenic immunosuppression (eg. cyclosporine; azathioprine, oral steroids) taken within the past month
- •Parathyroid disease
- •Acute or chronic renal disease
- •Hypercalcemia or hypocalcemia
- •Thyroid disease
- •History of osteomalacia or Paget's disease of bone
- •History of malabsorption (eg cystic fibrosis)
- •Planned trip to sunny climate during the one-month study
研究组 & 干预措施
2
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
1
Experimental
干预措施: cholecalciferol (vitamin D) (Dietary Supplement)
结局指标
主要结局
Investigator Global Assessment (IGA)
时间窗: 1 month
EASI score
时间窗: 1 month
次要结局
未报告次要终点
研究者
Carlos A. Camargo, Jr.
Physician
Massachusetts General Hospital
研究点 (1)
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