Effect of Vitamin D3 Supplementation to Reduce Respiratory Infections in Children and Adolescents in Vietnam: A Blinded, Placebo-controlled Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,300
- 试验地点
- 1
- 主要终点
- Laboratory-confirmed non-influenza infection
研究概览
简要总结
The goal of this study is to assess the effectiveness of vitamin D in reducing laboratory-confirmed influenza and in reducing non-influenza viral respiratory tract infections. A cohort of children between the ages of 3 and 17 years from the Thanh Ha Commune, Thanh Liem District, Ha Nam Province, Vietnam will be randomized to either weekly vitamin D supplements or placebo. Participants who develop acute respiratory infection over a 12-month period, will be tested for influenza, the co-primary outcome, and other respiratory viruses, the other co-primary outcome, by RT-PCR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 3 and 17
- •Residing in Thanh Liem District, Ha Nam Province, Vietnam
排除标准
- •Born prematurely at less than 32 weeks gestation
- •Any chronic illness (except asthma)
- •Currently using medication known to interfere with vitamin D metabolism
- •Children with a sibling participating in the study
研究组 & 干预措施
vitamin D supplements
children and adolescents that are randomized to the intervention will receive 7 mls of D-drops (14,000U/week of vitamin D) for eight months
干预措施: vitamin D supplements (Dietary Supplement)
vitamin D placebo
children and adolescents that are randomized to placebo will receive 7 mls of placebo drops for eight months
干预措施: placebo (Dietary Supplement)
结局指标
主要结局
Laboratory-confirmed non-influenza infection
时间窗: 12 months
Laboratory-confirmed influenza infection
时间窗: 12 months
次要结局
未报告次要终点