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
- 1
- 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
研究组 & 干预措施
Conventional vitamin D supplementation
Regular supplementation during pregnancy with 400IU vitamin D
Larger doses of vitamin D supplementation
The subjects enrolled in this arm will be supplemented during the third trimester of pregnancy with 2000IU vitamin D per day
干预措施: Vitamin D (Dietary Supplement)
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)