Randomized, Double-blind, Placebo Controlled Trial of Vitamin D3 Supplementation on Clinical, and Subjective Symptoms of Paediatric Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 主要终点
- Paediatic Asthma Control Test (P-ACT)
研究概览
简要总结
Epidemiological and observational studies have linked vitamin D deficiency with increased asthma/allergy incidence . Vitamin D insufficiency (<75nmol/L) has been associated with increased incidence of severe childhood asthma. Further, high 25(OH)D levels were associated with reduced risk of recent hospitalization, lower use of anti-asthmatic medication and lower airway hyper-responsiveness in childhood asthmatics. The association between vitamin D and allergy and asthma appears to be stronger in children than adults, with some even suggesting that childhood asthma may may be caused by VDD.
详细描述
Asthmatic children will be recruited in winter. After baseline testing, children will be randomized to take 2,000iu vitamin D or placebo daily for 15 weeks. After the 15 weeks, testing will be repeated. Tests involve blood draws, questionnaires and breathing tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous clinical diagnosis of asthma
- •Ability to perform pulmonary function tests
- •Established on anti-asthmatic pharmacotherapy with no expected change
排除标准
- •Use of medications that influence vitamin D metabolism or absorption
- •Chronic, non-asthma medical issues e.g. endocrine, hepatic, renal, or bone-disease
研究组 & 干预措施
Placebo
An identical placebo capsule daily for 15 weeks.
干预措施: Placebo (Dietary Supplement)
Intervention
2,000iu vitamin D3 per day for 15 weeks
干预措施: Placebo (Dietary Supplement)
Intervention
2,000iu vitamin D3 per day for 15 weeks
干预措施: VItamin D3 (Dietary Supplement)
结局指标
主要结局
Paediatic Asthma Control Test (P-ACT)
时间窗: 15 weeks
次要结局
- Biochemical markers (25(OH)D, total IgE, total calcium, albumin, PTH, phosphate, hsCRP, IgA and ECP.(15 weeks)
- Mini paediatric asthma quality of life questionnaire(15 weeks)
- Global Initiative for Asthma Score(15 weeks)
- Height velocity(15 weeks)
- Pulmonary function(15 weeks)
- Asthma Diary(15 weeks)
研究者
Conor Kerley
PhD candidate
University of Dublin, Trinity College