Efficacy and safety of vitamin D supplementation in asthmatic children who are vitamin D deficient: a randomized controlled trial (ESDAC trial)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- 1.Proportion of children having Childhood Asthma Control Test score 20 or more at end of the treatment.
研究概览
简要总结
Asthma is one of the most common chronic diseases in children with considerable morbidity. Vitamin D is found to have many extra-osteoarticular functions. Vitamin D had significant immunological effects and may have potential role in pathogenesis of asthma. The link between vitamin D levels, prevalence of asthma, lung function, asthma control, and airway structure suggest that vitamin D supplementation may be beneficial in persistent asthma in children. Therefore, we aim to evaluate efficacy and safety of vitamin D supplementation in children with persistent asthma who are vitamin D deficient. In this double blind randomized controlled trial, 250 children of 4 to 12 years of age with persistent asthma will be randomized to receive either vitamin D supplementation or placebo supplementation for nine months, in addition to standard therapy. Primary outcomes of study are proportion of children with childhood asthma control test (CACT) score of 20 or more at end of the treatment and adverse effects. Total duration of study will be two years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children 4 to 12 years of age.
- •Physician diagnosed persistent asthma receiving regular inhaled corticosteroids.
- •All (mild, moderate, and severe) persistent asthma receiving any dose of inhaled steroids will be eligible for study.
- •Both old and new cases of persistent asthma and all types (atopic, non-atopic) of persistent asthma will be included for study.
- •(3) Vitamin D levels < 20 ng/ml.
排除标准
- •Clinically having rickets.
- •Children with chronic diseases like chronic renal failure, chronic liver disease, or any bone disease.
- •Mental retardation.
- •Receiving vitamin D supplementation.
- •Received a mega dose of vitamin D (3 lac-6 lac units) in last one month.
- •Any patient that in the opinion of investigators is unlikely to follow up.
- •Participation in any other clinical trial within 3 months prior to enrolment 8)Parents not giving consent.
结局指标
主要结局
1.Proportion of children having Childhood Asthma Control Test score 20 or more at end of the treatment.
时间窗: At nine months
2. Adverse effects.
时间窗: At nine months
次要结局
- Number of courses of oral steroids use(Throughout study)
- Proportion of children having CACT score 20 or more at end of follow up(At nine months)
- Change in mean CACT score from baseline to end of the treatment(at nine months)
- Change in forced expiratory volume in first second (FEV1), FVC/FEV1, and PEFR by from baseline to end of the treatment(At nine months)
- Number of emergency visits(Throughout study)
- Height gain from enrollment to final follow-up(At nine months)
- Number of days requiring rescue medications and number of night awakenings(Throughout study)
- Total dose of inhaled steroids(Throughout study)
- Change in vitamin D levels(At nine months)