The Effect of Vitamin D Administration to Premature Infants on Vitamin D Status and Respiratory Morbidity During the First Year of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Improved serum vitamin D levels in the intervention group (receiving 800 IU daily) in comparison to the control group (receiving 400 IU daily)
研究概览
简要总结
This trial objective is to assess whether doubling the daily intake of vitamin D improves serum vitamin D levels and serves as primary prevention of respiratory infections and asthma in premature infants.
This is a prospective randomized (1:1) double-blinded trial.
The study population will be randomized into two groups (1:1):
- Intervention Group - 800 IU of Vitamin D once daily
- Control Group - 400 IU of Vitamin D once daily Patients will be followed up for one year after randomization for serum Vitamin D levels and respiratory morbidity.
详细描述
The rational of this trial is that a daily supplementation of a double dose of Vitamin D (800 IU instead of 400 IU) to late premature infants during the first year of life will result in elevated Vitamin D serum levels and in an improvement in respiratory morbidity.
This randomized trial of vitamin D supplementation is planned to determine the optimal dose of daily vitamin D supplementation required to achieve sufficient vitamin D levels in preterm infants and to assess whether doubling the daily intake of vitamin D may serve as primary prevention of respiratory infections and asthma in premature infants.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 33 Weeks 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm infant born at 32+6 to 36+6 weeks of gestational age
- •Born at Soroka University Medical Center
- •Signed informed consent
- •Participants in the trial will be insured by "Clalit" HMO
排除标准
- •Chromosomal abnormality
- •Neurological or muscular congenital anomalies
- •Congenital cardiac defect
- •Congenital respiratory anomalies
- •Congenital GIT/ liver/ renal anomalies that effect the absorption and/or metabolism of Vitamin D and/or other substances.
- •Admission after birth to NICU persists more than 5 days
结局指标
主要结局
Improved serum vitamin D levels in the intervention group (receiving 800 IU daily) in comparison to the control group (receiving 400 IU daily)
时间窗: 12 months of age
次要结局
- respiratory morbidity prevalence(first year)
研究者
Inbal Golan- Tripto MD
Pediatrics pulmonologist
Soroka University Medical Center