Impact of Nutrient Supplementation on Breast Milk Levels of Lactating Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 6
- 主要终点
- Breast milk concentration of carotenoids
研究概览
简要总结
To investigate the impact of nutrient supplementation during lactation on levels in breast milk.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects will be eligible for the study if they meet all of the following inclusion criteria:
- •Mother with singleton birth, 37-42 weeks gestation and ≥ 2490g
- •Pre-pregnancy BMI </= 30
- •Mother is ≥ 18 years of age
- •Mother is 4-6 weeks postpartum and has been successfully continuously lactating
- •Mother agrees to abstain from the use of any Docosahexaenoic acid (DHA), lutein and/or vitamin E containing supplements for at least 10 days prior to providing a baseline breast milk sample
- •Mother agrees to abstain from the use of non-study supplements throughout the study
- •Mother plans to continue breastfeeding for at least 6 weeks from the start of the study
- •No significant ongoing medical problems in the infant as determined from infant's medical history as related by the parent(s) to the enrolling center personnel
排除标准
- •Subjects will be excluded from the study if they meet any of the following criteria:
- •Subject had adverse maternal and/or fetal medical history
- •Subject is participating in a non-Abbott approved concomitant trial
- •Mother is taking cholesterol medication and/or medication affecting lipid absorption and/or transport
研究组 & 干预措施
Control Supplement
soft-gel placebo capsules, 2 capsules from the placebo bottle per day
干预措施: Placebo (soybean oil and dl-alpha-tocopheryl acetate) (Dietary Supplement)
Experimental Supplement A
soft-gel capsules; 1 capsule from the experimental bottle and 1 capsule from the placebo bottle per day
干预措施: Similac Prenatal Vitamin soft-gel capsule (Dietary Supplement)
Experimental Supplement A
soft-gel capsules; 1 capsule from the experimental bottle and 1 capsule from the placebo bottle per day
干预措施: Placebo (soybean oil and dl-alpha-tocopheryl acetate) (Dietary Supplement)
Experimental Supplement B
soft-gel capsules; 2 capsules from the experimental bottle per day
干预措施: Similac Prenatal Vitamin soft-gel capsule (Dietary Supplement)
结局指标
主要结局
Breast milk concentration of carotenoids
时间窗: 1 - 43 days
次要结局
- Breast milk concentration of fatty acids(1 - 43 days)