NCT02069522终止不适用
Healthy Term Infants Fed Milk-Based Formulas With A Supplemental Carotenoid
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 91
- 试验地点
- 6
- 主要终点
- Carotenoid Concentration
研究概览
简要总结
This is a prospective, double blind, crossover study in healthy infants randomized to one of two study formulas. The trial will consist of two 21 day study feeding periods separated by a study washout period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infant is in good health
- •Infant is a singleton from a full term birth with a gestational age of 37-42 weeks
- •Infant's birth weight was > 2490 g (~5 lbs 8 oz)
- •Infant is between 14 and 28 days of age
- •Parent(s) confirm intention to feed their infant the study product(s) as the sole source of nutrition for the duration of the study
- •Parent(s) confirm intention not to administer vitamin or mineral supplements, DHA and ARA supplements, solid foods/juices to their infant from enrollment through the duration of the study
排除标准
- •An adverse maternal, fetal or infant medical history that has potential for effects on tolerance, growth, and/or development.
- •Infants using medications (including OTC), home remedies, herbal preparations, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance
研究组 & 干预措施
Standard Milk-based Formula Containing Carotenoid
Active Comparator
milk-based ready to feed infant formula
干预措施: Standard Milk-based Formula Containing Carotenoid (Other)
Investigational Milk-based Formula Containing Carotenoid
Experimental
investigational milk-based ready to feed infant formula
干预措施: Investigational Milk-based Formula Containing Carotenoid (Other)
结局指标
主要结局
Carotenoid Concentration
时间窗: Change from Baseline to end of Study Period A (~21 Days)
Plasma sample
次要结局
- Carotenoid Concentration(Change from Baseline to end Study Periods A (~21 Days) and B (~21 Days))
研究者
研究点 (6)
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