Vitamin D Supplementation During Pregnancy for Prevention of Asthma in Childhood: An Interventional Trial in the ABC (Asthma Begins in Childhood) Cohort
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Persistent wheeze
研究概览
简要总结
The aim of this study is to prevent asthma symptoms (recurrent wheeze) in childhood by supplementation with high dose vitamin D to the mother during pregnancy. Participants are mothers and children of the ABC (Asthma Begins in Childhood) cohort. Mothers are recruited during pregnancy and receive daily supplement with 2400 IU of Vitamin D3 or placebo from week 24 og gestation to 1 week after delivery. In addition all mothers are advised to take the recommended dose of 400 IU vitamin D daily. The mothers in ABC also participate in an interventional trial with fish oil supplementation, and the vitamin D randomization is stratified by fish oil treatment group. The child is followed with acute and planned vits at the research unit, and wheeze is diagnosed according to predefined algorithms.
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 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant in week 22-26 of gestation
- •Participating in the ABC-cohort
- •Living in Sealand, Denmark
- •Fluent in Danish
- •Willing to let the child participate in the study
排除标准
- •Intake of more than 400 IU of vitamin D during the last 6 months
- •Endocrinological disease such as calcium metabolic disorder, parathyroid disorder, thyroid disorder or Diabetes type 1
- •Tuberculosis
- •Sarcoidosis
- •In need of diuretics or heart medication including calcium channel blockers
研究组 & 干预措施
Vitamin D
Dietary supplement: 2400 IU Vitamin D3 (2 tablets of 1200 IU) from week 24 of gestation to 1 week after delivery
干预措施: Cholecalciferol D3 (Dietary Supplement)
Placebo
Placebo: 2 placebo tablets with no active substance, identical to the active tablets, from week 24 of gestation to 1 week after delivery
干预措施: Placebo tablet (Other)
结局指标
主要结局
Persistent wheeze
时间窗: 0 to 3 years of age
Age at onset of persistent wheeze diagnosed according to predefined algorithm of recurrent troublesome lung symptoms, response to treatment and relapse after withdrawal of treatment
次要结局
- Allergic sensitization(6 and 18 months of age)
- Dental health(6 year)
- Infections(0 to 3 years of age)
- Asthma exacerbations(0 to 3 years of age)
- Systemic immune status(18 months)
- Eczema(0 to 3 years of age)
- Mothers levels of 25-OH-Vitamin D, PTH, Calcium, alkaline phosphatase(1 week after delivery)
- Growth(0-3 years)
- Neurological development(0-3 years)
- Airway mucosal immune status(4 weeks and 2 years)
- 17q21 genotype and sphingolipid metabolites(6 months)
- Growth(0 to 3 years of age)