NCT00465764已完成2 期
Pilot Tolerance and Bone Status of Healthy, Term Infants Fed Infant Formulas
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Mean rank stool consistency at 14 days of age
研究概览
简要总结
To compare the tolerance and early bone status of healthy, term infants fed formulas during the first three months of life.
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
- 1 Day 至 8 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy term infants;
- •Age 0-8 days of age;
- •Exclusively formula fed;
- •No use of vitamin/mineral supplements.
排除标准
- •Maternal, fetal or perinatal medical history thought to have potential for negative effects on tolerance, growth or development.
研究组 & 干预措施
Standard infant formula
Active Comparator
Feed as per HCP instructions
干预措施: Standard infant formula (Other)
Protein formula
Experimental
Feed as per HCP direction
干预措施: Alternate protein infant formula (Other)
结局指标
主要结局
Mean rank stool consistency at 14 days of age
时间窗: 14 days of age
次要结局
- Blood chemistries, bone mineral content, percent of feedings with spit-up or vomit associated with feeding(14 days)
研究者
研究点 (2)
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