NCT00716105已完成不适用
Effect of the Level of Dietary Protein on Infant Growth and Body Composition in the First Year of Life
Société des Produits Nestlé (SPN)4 个研究点 分布在 1 个国家目标入组 405 人开始时间: 2008年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 405
- 试验地点
- 4
- 主要终点
- Mean weight gain
研究概览
简要总结
The purpose of this study is to determine whether infants fed a formula with protein levels different than a standard infant formula have similar growth and development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gestational age at least 37 weeks
- •Singleton birth
- •Birth weight between 2500g and 4500g
- •Weight at enrolment is at or above the 5th percentile (CDC)
- •Infant has been exclusively formula fed for at least the last 14 days
- •Having obtained informed consent of legal representative
排除标准
- •Congenital illness or malformation that affects infant feeding and/or growth
- •Significant pre-natal and/or post-natal disease
- •Suspected or confirmed allergy to cow milk protein
- •In the investigators assessment, infant's family cannot be expected to comply with treatment (feeding regimen)
- •Currently participating in another clinical trial
结局指标
主要结局
Mean weight gain
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (4)
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