Real time identification of common pathogens causing acute respiratory tract infection in children below 14 years of age and role of vitamin D supplementation in reduction of ARTI
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Various pathogens responsible for ARTI in children will be identified & The percentage of bacterial, viral and coinfections will be calculated.
研究概览
简要总结
This study is a stratified randomized control trail in which participants are selected based on the inclusion and exclusion criteria. Identification of various pathogens responsible for ARTI in children below 14 yrs of age and percentage of bacterial, viral and bacterial - viral coinfection will be calculated. The level of vitamin D and Interleukin 6 (IL6) in serum will be checked and the participants with vitamin D deficiency and insufficiency will be identified. The participants where divided into three groups (No Pneumonia, Pneumonia and Severe Pneumonia) based on the symptoms and each group will be divided into two groups (Intervention & Control) based on the vitamin D deficiency and insufficiency. The intervention group will receive vitamin D supplement 60000 IU, weekly once for 3 months. patients will be followed up during their intervention. After a period of 3 months of intervention, the serum Vitamin D, IL6 level and the Persistent infection will be checked. Primary outcome will be the identification of various pathogens and calculation of percentage of each pathogen and its coinfection will be assessed. Secondary outcome is the level of vitamin D is associated with the severity of infection / helps in the reduction of recurrent infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Month(s) 至 14.00 Year(s)(—)
- 性别
- All
入选标准
- •Children below 14yrs of age in hospitalized children.
- •Children with acute respiratory infection.
排除标准
- •Newborn below 1 month.
- •Infants with congenital disorders (Heart defects, Neural defects, Down syndrome, etc…) 3) Infants with immunodeficiency.
- •Patients having chronic inflammatory, autoimmune disorders, renal disease, and malignancies.
结局指标
主要结局
Various pathogens responsible for ARTI in children will be identified & The percentage of bacterial, viral and coinfections will be calculated.
时间窗: 2 YEARS
次要结局
- We can find whether Vitamin-D supplementation is associated with the severity of infection.(2 years)
研究者
Gayathri G
SRM Medical College Hospital and Research Centre
