A Randomized, Double-blind, Controlled Trial of Vitamin D for the Prevention of Acute Respiratory Infections in Children Aged 18 to 36 Months in Santiago, Coyhaique and Punta Arenas, Chile
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 276
- 试验地点
- 3
- 主要终点
- Incidence of acute respiratory tract infections
研究概览
简要总结
The main purpose of this study is to determine whether weekly oral vitamin D supplementation is effective to prevent acute respiratory tract infections in children. The hypothesis of the study is that vitamin D supplementation reduces the incidence and severity of acute respiratory tract infections in children.
详细描述
Acute respiratory tract infections (ARTIs) are associated with high levels of morbidity and socioeconomic impact, particularly affecting young children. Observational studies have shown an association between vitamin D (VD) deficiency and higher incidence and severity of respiratory infections. Chile has a high prevalence of VD deficiency, particularly in the southern regions of the country. The objective of this study is to evaluate the safety and efficacy of oral VD supplementation to decrease the incidence of ARTIs in 275 preschool children. A randomized, placebo-controlled, double-blind study will be performed in Santiago, Coyhaique and Punta Arenas. Children aged 18 to 36 months will be given weekly oral 5600 IU of vitamin D3 (VD3), 11200 IU of VD3, or placebo doses during 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 18 to 36 months attending daycare in Santiago, Coyhaique or Punta Arenas.
排除标准
- •History of chronic illness requiring immunosuppression
- •History of metabolic bone disease
- •Use of vitamin D supplementation greater than 400 IU daily, either by milk formula or vitamin supplements in the last 3 months.
- •Use of fish oil supplements in the last 3 months.
- •Immunodeficiency
- •Planned trip to sunny climate during study period.
研究组 & 干预措施
Placebo
Oral placebo in liquid weekly during 6 months
干预措施: Placebo (Dietary Supplement)
Oral 11200 IU Vitamin D3 weekly
Oral 11200 IU Vitamin D3 in liquid weekly during 6 months
干预措施: Vitamin D3 (Dietary Supplement)
5600 IU Vitamin D3
Oral 5600 IU Vitamin D3 in liquid weekly during 6 months
干预措施: Vitamin D3 (Dietary Supplement)
结局指标
主要结局
Incidence of acute respiratory tract infections
时间窗: 6 months
次要结局
- Adverse events(6 months)
- serum 25-hydroxyvitamin D levels(6 months)
- Viral etiology of ARTIs(6 months)
- Hospitalizations due to acute respiratory tract infections(6 months)
- Serum cathelicidin levels(6 months)
- Bone metabolism parameters(6 months)