Vitamin D Intervention in Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Growth
研究概览
简要总结
The study is a randomized, controlled, double blinded study evaluating the effect of recommended (400 IU) and 1 200 IU daily vitamin D substitution, given from 2 weeks to 2 years of age, on growth, bone development, neurologic and cognitive development, frequence of infectious diseases, allergic symptoms, and development of immunoregulation assessed at 2 years of age.
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 5 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants born at term (37-42 wks, weight appropriate for gestational age) are included in the study
排除标准
- •Non Caucasian mother
- •Any continuous regular medication of mother
- •Treatment at neonatal intensive care unit
- •Antibiotic treatment of the infant
- •Congenital malformations of the newborn
- •Treatment with ventilation support (continuous nasal positive airway pressure) for over 24 hours
- •Glucose infusion of the newborn
- •Neurological symptoms of the newborn
- •Phototherapy for jaundice of the newborn
- •Need for nasogastric feeding of the newborn
研究组 & 干预措施
Vitamin D supplement
Vitamin D supplement according to national guidelines (10 ug/day) from 2 weeks to 2 years of age
干预措施: Vitamin D at 10 ug/day (Dietary Supplement)
Vitamin D supplement at 30 ug/day
Vitamin D supplement at 30 ug/day from 2 weeks to 2 years of age
干预措施: Vitamin D at 30 ug/day (Dietary Supplement)
结局指标
主要结局
Growth
时间窗: 2 years of age
Measurement of growth at 2 years of age
Neurologic and cognitive development
时间窗: At 2 years of age
By means of questionnaires and, on a randomly selected group of study subjects, cognitive function testing to assess neurologic and cognitive development
Frequency of allergic symptoms and infection
时间窗: At 2 years of age
Assessment of the frequency of allergic symptoms and infections by means of questionnaires, hospital discharge records and prescription data.
Development of immunoregulation
时间窗: At 2 years of age
Assessment of the tolerogenic properties of T-cells and dendritic cell function from blood sample in a subgroup of 100 study subjects.
Bone mineral density
时间窗: 2 years of age
Bone mineral density is measured by dual energy x-ray absorptiometry and peripheral quantitative computerized tomography
次要结局
未报告次要终点
研究者
Sture Andersson
Professor of Neonatology
Helsinki University Central Hospital