NCT00941564已完成4 期
"Comparative Calcium Absorption and Gastrointestinal Tolerance in Healthy Term Infants Fed Milk-based Formulas With Different Fat Blends"
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Calcium absorption
研究概览
简要总结
The objective is to assess the comparative calcium absorption and gastrointestinal (GI) tolerance in healthy normal term infants fed two commercially available powdered milk-based formulas which contain 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 84 Days 至 159 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infant in good health, full term, singleton birth and 84-156 days of age at enrollment. Male infants only to be enrolled for primary variable measures.
- •Restrict use of certain medications or home remedies, herbal preparations, probiotics or rehydration/intravenous (IV) fluids.
排除标准
- •Adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- •Infant has been treated with antibiotics 3 days prior to enrollment.
- •Infant has received probiotics-containing products 3 days prior to enrollment.
研究组 & 干预措施
Commercially available infant formula A
Experimental
Varying fat blend from comparator product
干预措施: Infant Formula milk based (Other)
Commercially available infant formula B
Active Comparator
干预措施: Infant formula milk based (Other)
结局指标
主要结局
Calcium absorption
时间窗: 18 days
次要结局
- Calcium retention, fat absorption, tolerance(18 days)
研究者
研究点 (1)
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