Calcium Plus Vitamin D Supplementation During Pregnancy of Adolescent Mothers: Effects on Maternal and Infant Bone Mass, Calcium and Bone Metabolism and Breast Milk Composition
试验速览
- 阶段
- 不适用
- 入组人数
- 76
- 主要终点
- Differences in maternal bone mass changes postpartum between supplemented and placebo groups
研究概览
简要总结
Pregnancy and lactation are periods of high calcium requirement. Inadequate maternal calcium intake and vitamin D insufficiency may adversely affect fetal and neonatal growth and maternal bone mass particularly in adolescent mothers. The investigators propose to evaluate the influence of calcium plus vitamin D supplementation during pregnancy on bone mass of lactating adolescent mothers with habitually low calcium and vitamin D, on fetal growth and neonate bone mass. Mothers are randomly assigned to receive daily calcium (600 mg) plus vitamin D3 (200 IU) supplement or placebo from mid gestation until parturition. Fetal growth parameters are assessed by standard ultrasound techniques at mid and late gestation. Maternal bone mass is assessed by dual energy x-ray absorptiometry (DXA) at 2 and 5 months postpartum and 6 months after weaning. Infant bone mass is assessed by DXA at 2 months postpartum.
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
- Single (Participant)
入排标准
- 年龄范围
- 13 Years 至 19 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •13-19 y old
- •between 23 and 29 wk of gestation
- •primiparous
- •carrying single fetus
- •intending to exclusively or predominantly breastfeed
排除标准
- •chronic health problems
- •users of nutritional supplements, except iron supplements provided during standard prenatal care
结局指标
主要结局
Differences in maternal bone mass changes postpartum between supplemented and placebo groups
时间窗: 2, 5 and 12 months postpartum
Differences in fetal growth and infant bone mass between supplemented and placebo groups
时间窗: 2nd and 3rd trimester gestation and 2 mo postpartum
次要结局
- Differences in changes of bone and calcium related hormones and vitamin D status between supplemented and placebo groups(2nd and 3rd trimester of pregnancy and 2, 5, 12 mo postpartum)
- Differences in human breast milk composition (nutrients and hormones) between supplemented and placebo groups(2 months postpartum)
- Differences in maternal bone status according to vitamin D receptor (VDR) polymorphisms(2, 5 and 12 months postpartum)
- Differences in infant body composition between supplemented and placebo groups(2 months postpartum)
- Differences in changes of maternal body composition postpartum between supplemented and placebo groups(2, 5 and 12 months postpartum)
研究者
Flavia Fioruci Bezerra
DSc
Rio de Janeiro State University