NCT01617889已完成3 期
Healthy Term Infants Fed Milk-Based Formulas With Different Fat Blends
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- calcium absorption
研究概览
简要总结
The objective is to assess the comparative fat and calcium absorption, and gastrointestinal (GI) tolerance in healthy normal term infants fed powdered milk-based formulas containing different fat blends.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 53 Days 至 115 Days（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 singleton from a full term birth
- •Infant's birth weight was > 2490 g.
- •Infant is between 53 and 115 days of age
- •Infant is on infant formula and tolerating infant formula feedings
- •Parent(s) confirm they will not administer vitamin or mineral supplements, solid foods or juices for the duration of the study, unless instructed otherwise by their healthcare professional.
- •Parent(s) and physician agree to discontinue the use of medications or home remedies, herbal preparations that might affect GI tolerance
排除标准
- •Infant has received human milk within 7 days prior to SDay
- •Any adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development and includes maternal substance abuse
- •Infant has been treated with antibiotics within 5 days prior to SDay 1
- •Infant has received probiotics within 5 days prior to SDay 1.
结局指标
主要结局
calcium absorption
时间窗: 8 days
as measured in stool
次要结局
- percent of feedings with spit up/vomit associated with feeding per day.(28 days)
- stool consistency(28 days)
- fat absorption(8 days)
- average number of stools per day(28 days)
研究者
研究点 (2)
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