The Effect of Different Doses of Vitamin D Supplementation During Pregnancy on Bone and Vitamin D Status in Children at Birth and at One Year Age
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Bone status in offspring at the age of one year as assessed by tibial and radius quantitative ultrasound (QUS).
研究概览
简要总结
Vitamin D deficiency is frequently reported in pregnant women despite recommendation of daily vitamin D supplementation of 400IU/d. Recent studies have shown that in the absence of sun exposure these doses are seldom able to achieve 25(OH)D optimal serum levels.
We hypothesize that larger doses of vitamin D are needed to be supplemented to all women during pregnancy. We hypothesize that this may have advantageous effects on maternal vitamin D and bone reserve as well on offspring vitamin D and bone status at birth and possible further on.
The aim of the present study is to compare vitamin D and bone status of infants born to mothers supplemented with 400IU/d (present recommendations) and 2000IU/d vitamin D during the third trimester of pregnancy.
详细描述
This is a prospective randomized controlled study.
120 pregnant women will be recruited at 27 weeks gestation and randomized into two treatment groups; 400IU/d or 2000IU/d vitamin D supplementation from 27 weeks until delivery.
25-hydroxyvitamin D (25OHD), parathyroid hormone (PTH), urinary calcium/creatinine and serum calcium and alkaline phosphatase (ALP) levels will be assessed in mothers at 27 weeks and at delivery.
25OHD, calcium and ALP levels, and urinary calcium/creatinine will be evaluated in offspring at birth and at one year age.
Vitamin D and calcium intake and sun exposure will be evaluated in mothers and offsprings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy pregnant women aged 20 to 40 years, of any parity status.
- •Signed informed consent
排除标准
- •Presence of diseases known to affect vitamin D status such as malabsorption states, liver and renal disorders, primary and tertiary hyperparathyroidism, granulomatous disorders
- •Treatment with medications known to affect vitamin D status such as anticonvulsivants, glucocorticoids, antirejection medication and retroviral agents
结局指标
主要结局
Bone status in offspring at the age of one year as assessed by tibial and radius quantitative ultrasound (QUS).
时间窗: Bone status in offsprings, assessed at the age of one year
次要结局
- Vitamin D status of mothers.(At the start of intervention, at delivery and at the age of one year)
- Maternal health status.(At the start of intervention, at delivery and at the age of one year)
- Infants' growth.(At the start of intervention, at delivery and at the age of one year)
- Vitamin D status in infants.(At the start of intervention, at delivery and at the age of one year)
- Safety of vitamin D supplementation doses.(At the start of intervention, at delivery and at the age of one year)