NCT00970398Unknown不适用
Effect of Infant Formula With Bovine Milk Osteopontin on Infant Growth, Health and Immune functions-a Double-blind Randomized Trial
Biostime, Inc.1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2009年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Concentrations of immune cells and cytokines of IL-6, IL-10, and IL-12 in infant's blood samples will be measured to evaluate immune functions.
研究概览
简要总结
The specific objectives of this study are to evaluate the effects of bovine milk osteopontin added to infant formula on infant growth, health and immune functions.
详细描述
Breast-fed infants will be used as a reference group and formula-fed infants will be fed control formula or the same formula supplemented with Osteopontin at a concentration 50% or 100% of that of breast milk. The hypothesis is that supplementation of bovine milk Osteopontin in infant formula will have positive effects on infant growth, health and immune functions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mothers Inclusion Criteria:
- •Healthy, 19-40 years of age
- •Plan to exclusively breast-fed or formula-fed
排除标准
- •Gestational age < 37 or > 42 weeks
- •Birth weight < 2.5kg or > 4 kg
- •Having congenital diseases
- •Having birth Asphyxia
- •Having birth infections
结局指标
主要结局
Concentrations of immune cells and cytokines of IL-6, IL-10, and IL-12 in infant's blood samples will be measured to evaluate immune functions.
时间窗: 1, 4, and 6 postnatal months
次要结局
- Anthropometric parameters: body length, body weight, and head circumferences at each visit.(1, 2, 3, 4, 5, and 6 postnatal months)
- Dietary, stool consistency and well being recorded by 3 day questionnaires(1, 2, 3, 4, 5, and 6 postnatal months)
- Adverse events and concomitant medications recorded by heath forms as a measure of safety and tolerability.(1, 2, 3, 4, 5, and 6 postnatal months)
研究者
研究点 (1)
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