NCT02144402已完成不适用
Growth of Healthy Term Infants Fed Formula Containing DHA-B
dsm-firmenich Switzerland AG20 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2014年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 159
- 试验地点
- 20
- 主要终点
- weight gain (gm/day)
研究概览
简要总结
The primary objective is to determine if the weight gain of healthy term infants fed a commercially available term infant formula supplemented with DHASCO® is similar to that of infants fed the same formula supplemented with a new product, DHASCO®-B.
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 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •full term infant (gestational age 37-42 weeks)
- •birth weight > or equal to 2500 g
- •singleton infant < or equal to 14 days of age in good health
- •parent must be >21 years of age
- •parental consent
排除标准
- •congenital malformation or genetic disorder
- •metabolic anomalies
- •maternal infectious diseases, alcoholism, substance abuse
- •mothers with gestational diabetes
- •participation in another clinical study
研究组 & 干预措施
infant formula with DHASCO
Active Comparator
standard infant formula with docosahexaenoic acid (DHA)
干预措施: infant formula with DHASCO (Other)
infant formula with DHASCO-B
Experimental
standard infant formula with DHA-B
干预措施: infant formula with DHASCO-B (Other)
结局指标
主要结局
weight gain (gm/day)
时间窗: through day of life 120
gm/day -calculated from the weight measured at enrollment subtracted from the weight measured at DOL 120 visit, divided by the number of days between the actual visits.
次要结局
- Formula intake and tolerance(Day of life 30 and 120)
- head circumference (cm)(through day of life 120)
- fatty acid levels (wgt %)(at day of life 120)
- length (cm)(through day of life 120)
研究者
研究点 (20)
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