Does Oral Vitamin D Supplementation in Egyptian Infants With Acute Bronchiolitis Improve the Outcome? A Double Blind Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- length of hospital stay
研究概览
简要总结
This study was conducted to evaluate the effect of oral vitamin D supplementation on the clinical course of acute bronchiolitis, and to investigate whether vitamin D deficiency among infants who required hospital-based care for bronchiolitis is associated with the severity of the acute episode.
详细描述
This is a double blind randomized controlled trial which was conducted on 60 infants who required hospital-based care for acute bronchiolitis. The patients were recruited in the period from October 2018 to January 2019. Informed consents were obtained from all caregivers, and approved by Institutional Research Board of our University.
The diagnosis of acute bronchiolitis was based on a first episode of respiratory distress with wheezing and/ or crackles, preceded by an infection of the upper airways (rhinorrhea, coryza, cough, fever). Disease severity was evaluated using Modified-Tal scoring systems for bronchiolitis, since it is repeatable and can reliably be used in research and clinical practice
Sample size:
Our hospital data have shown that the mean LOS for cases admitted with acute bronchiolitis was 3 ± 2 days. Assuming a reduction in length of hospital stay by 50% and study power of 80% to detect a clinical significance (α error) of 0.05 between interventional groups, we calculated a sample size of 30 patients in each treatment group.
Randomization and Enrollment:
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
- 1 Month 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants aged 1-24 months of age, diagnosed clinically as acute bronchiolitis and presented with any of the following:
- •Persistent resting oxygen saturation below 92% in room air.
- •Marked tachypnea.
- •Intercostal retractions indicating respiratory distress.
- •Inability to maintain oral hydration.
- •Parent unable to care for child at home.
排除标准
- •Infants with history of prematurity (< 37 weeks), chronic cardiopulmonary disease, immunodeficiency, neuromuscular disease, and any other chronic medical condition.
- •Patients receiving any micronutrient supplementation or therapies containing vitamin D for 4 weeks prior to the study period.
- •Infants with previous episodes of wheezing or a physician's diagnosis of asthma.
- •Patients with acute bronchiolitis having very severe clinical score.
研究组 & 干预措施
Intervention group
cholecalciferol at dose of 100 IU/Kg/day
干预措施: Cholecalciferol (Drug)
Placebo group
placebo
干预措施: Placebo (Other)
结局指标
主要结局
length of hospital stay
时间窗: 3 to 5 days
Length of hospital stay in days
次要结局
未报告次要终点
研究者
Amal Osman
Lecturer of Pediatrics, Mansoura University
Mansoura University