Randomized Control Trial of Vitamin D Supplementation During Lactation on Vitamin D in Maternal Milk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Comparison serum 25OHD levels from breastfed infants
研究概览
简要总结
This randomized, placebo-controlled trial in Thai pregnancy is conducted. The study aims to determine whether vitamin D3 1,800 IU/d supplementation in lactating mother improves vitamin D status of breastfed infant.
详细描述
Vitamin D deficiency in pregnancy increases risk of gestational diabetes mellitus, pre-eclampsia, preterm birth, low birth weight and cesarean section. To against these adverse events, vitamin D supplementation in pregnancy and lactation is recommended, but dose ranges are varied. Then, this study is carried out in lactating mothers and their breastfed infants with maternal 25 Hydroxy-vitamin D (25OHD) levels of 10-30 ng/ml in third trimester. Subjects are divided into 2 groups, one is randomly assigned to 1,800 IU/d compared with maternal and infant controls receiving placebo. Maternal serum 25OHD and milk VitD will be measured by LC-MS/MS during lactation, and on cord blood at 6 weeks breastfed infants. This study is submitted for ethical consideration by relevant Ethics committee.
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
- Double (Participant, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant Thai women and intends to deliver at Rajavithi Hospital
- •Insufficient Vitamin D levels (25(OH)D < 30ng/ml)
- •Gestational age at birth and no complications
排除标准
- •Age < 18 years old
- •Unintended to deliver at Rajavithi Hospital
- •Insufficient Vitamin D levels (25(OH)D < 10ng/ml)
研究组 & 干预措施
Calciferol,1800 IU/d supplement
The lactating mothers and their breastfed infants with maternal 25 Hydroxy-vitamin D (25OHD) levels of 10-30 ng/ml in third trimester were randomly assigned to 1,800 IU/d .
干预措施: Calciferol (Drug)
Placebo
The lactating mothers and their breastfed infants with maternal 25 Hydroxy-vitamin D (25OHD) levels of 10-30 ng/ml in third trimester were randomly assigned to receive placebo.
干预措施: placebo (Drug)
结局指标
主要结局
Comparison serum 25OHD levels from breastfed infants
时间窗: 6 weeks after delivery
次要结局
未报告次要终点