NCT01669655已完成不适用
Plasma Profile of Exclusively Breastfed Infants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Plasma carotenoids in breastfed infants
研究概览
简要总结
To characterize nutrient levels in breastfeeding infants and their mothers.
详细描述
The objectives of this study are (1) to characterize plasma lutein levels in breastfed infants in an Asian population where lactating mothers have diets habitually high in lutein and (2) investigate how blood lutein levels in breastfed infants vary according to lutein content of the mothers' milk in such a population.
研究设计
- 研究类型
- Observational
- 观察模型
- Family Based
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Weeks 至 16 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infant is judged to be in good health.
- •Infant is a singleton from a full term birth.
- •Infant's birth weight was > 2490 g.
- •Infant is between 6 weeks and 16 weeks (42 to 112 days).
- •Infant must have been exclusively breastfed at enrollment.
- •Mother's intake indicates a consumption of an average of at least three servings of fruit and/or vegetables per day.
- •Mother is a non-smoker.
- •Mother is in good health.
- •Mother confirms her intention to continue breastfeeding.
排除标准
- •An adverse maternal, fetal or infant medical history that is thought to have potential for effects on growth, and/or development.
- •Infants who have consumed medications or herbal preparations during past 14 days prior to enrollment.
- •Infants who have consumed any solid or liquid foods or juices prior to enrollment.
- •Infants who have received any supplements containing carotenoids prior to enrollment.
- •Mother who is consuming dietary supplements containing carotenoids.
- •Participation in another study that has not been approved as a concomitant study.
结局指标
主要结局
Plasma carotenoids in breastfed infants
时间窗: At visit 1 (enrollment)
次要结局
- Plasma carotenoids in mothers of breastfed infants(At visit 1 (enrollment))
- Dietary carotenoid intake of mothers of breastfed infants(At visit 1 (enrollment) and visit 2 (14 days))
- Carotenoid levels in breastmilk(At visit 1 (enrollment) and visit 2 (14 days))
研究者
研究点 (1)
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