Effect of Supplementation With Vitamin D on the Acute Bronchitis Prevention During the First Year of Life
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Percentage of children with acute bronchitis
研究概览
简要总结
A phase III multicenter randomized double blind clinical trial will be conducted. After obtaining written consent the infant will be randomized, during the first two weeks of life, to a study group to receive either 400 IU or 1,000 IU / day of vitamin D to the year of age.
Baseline and all follow up visits (2, 6, and 12 months of life) will include anthropometric measurements and a questionnaire about health issues. A blood sample will be obtained at baseline for analysis of 25OH vitamin D, and at 6 and 12 months for analysis of 25 OH vitamin D, and calcium.
Healthy term born infants of appropriate size for gestational age will be included. We will need to include 359 children in each group.
The primary objective of the study is to decrease the proportion of infants with acute bronchitis during the first year of life by supplementation of 1,000 IU/day vitamin D. Secondary otcomes are: To check that the administration of 1,000 IU/day vitamin D decreases the proportion of infants with upper respiratory tract infections, the proportion of children under one year of age hospitalized for acute bronchiolitis, and the demand on the healthcare system due to respiratory infections and absences from work for parents and achieves a higher proportion of children with adequate blood levels 25 OH vitamin D.
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
- — 至 19 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy term born infants of appropriate size for gestational age
- •Parents provide informed consent to participate
排除标准
- •Infants with small size for gestational age
- •Infants with gestational age < 37 weeks
- •Infants with congenital anomalies
- •Infants with chronic gastrointestinal tract, liver, kidney, heart, or neurological diseases
- •Infants with disorders of vitamin D or calcium metabolism or others inborn errors of metabolism
研究组 & 干预措施
Vitamin D3 1000 IU/day
Infants will be supplemented with vitamin D and/or placebo to receive a total amount of vitamin D3 of 1.000 IU/day during the first year of life, taking into account the vitamin D received with artificial milk
干预措施: Vitamin D3 (Drug)
Vitamin D3 1000 IU/day
Infants will be supplemented with vitamin D and/or placebo to receive a total amount of vitamin D3 of 1.000 IU/day during the first year of life, taking into account the vitamin D received with artificial milk
干预措施: Placebo (Drug)
Vitamin D3 400 IU/day
Infants will be supplemented with vitamin D and/or placebo to receive a total amount of vitamin D3 of 400 IU/day during the first year of life, taking into account the vitamin D received with artificial milk
干预措施: Vitamin D3 (Drug)
Vitamin D3 400 IU/day
Infants will be supplemented with vitamin D and/or placebo to receive a total amount of vitamin D3 of 400 IU/day during the first year of life, taking into account the vitamin D received with artificial milk
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of children with acute bronchitis
时间窗: 1 year
Check that the administration of a vitamin D dose of 1,000 U / day decreases the percentage of children with acute bronchitis during the first year of life
次要结局
- Number of episodes of upper respiratory infections reported by parents in the first year of life(1 year)