NCT01284907撤回不适用
Vit D to Treat Asthma in Children: a Randomized, Double-blind, Placebo-controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- A change from baseline in Peak expiratory flow rate
研究概览
简要总结
The purpose of this study is to determine whether vitamin D supplements can improve asthma control in children with moderate to severe asthma
详细描述
The proposed interventional study will clarify the role of vitamin D in preventing asthma exacerbations and in achieving better chronic asthma control in children with moderate to severe asthma.
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 (Care Provider, Investigator)
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
- •Physician diagnosed asthmatics and they should fulfill at least two of the following three criteria:
- •A minimum of three clinic visits for acute asthma within 1 year
- •Two or more asthma-related hospital admissions within 1 year, or
- •Steroid dependency, as defined by either 6 months of oral or 1 year of inhaled corticosteroid use
- •Age: 6-14 years old. The age group of 6 to 14 years old was chosen for two reasons:
- •Diagnostic accuracy of asthma is better in this age group as non-specific wheezers less than 6 years of age could be excluded.
- •Child should be able to use a peak flow meter and perform spirometry tests.
- •A positive specific IgE or a positive skin prick test for at least one airborne allergen.
排除标准
- •Children with mild intermittent and mild persistent asthma.
- •Asthmatic children who are currently on immunotherapy or anti IgE.
- •Asthmatic children with concomitant other medical problems.
- •Children who are younger than 6 yrs or older than 14 yrs.
- •Children with history of early life injury to airways like premature birth (< 36 weeks) or home use of oxygen.
- •Children with vitamin D deficiency. Since these children may be randomized to the control group, they will be excluded for ethical reasons.
结局指标
主要结局
A change from baseline in Peak expiratory flow rate
时间窗: up to six months
次要结局
- A change from baseline in lung function test(up to six months)
研究者
研究点 (4)
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