NCT01658267已完成3 期
Compliance With Dietary Recommendations in Meeting Nutritional Requirements in Children at Risk of Undernutrition
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Compliance with recommendation of a nutritional supplement consumption
研究概览
简要总结
This study will assess compliance with dietary recommendations, in conjunction with a nutritional supplement to meet the nutritional requirements in children and the effects of the compliance on promoting growth in children who are at risk of under-nutrition.
详细描述
This study will assess compliance with dietary recommendations, in conjunction with an oral nutritional supplement to meet the nutritional requirements in children older than 36 (>36) to less than or equal 48 (≤48) months of age, and the effects of the compliance on promoting catch-up growth and normal healthy growth in children who are at risk of under-nutrition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 36 Months 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child is between 36 and 48 months of age.
- •Child has weight-for-height greater than or equal to 5th and less than or equal to the 25th percentile.
- •Child is capable of oral feeding.
- •Child's parent(s)or Legal Guardian is willing to abstain from giving additional non-study nutritional supplements to the child throughout the study period.
排除标准
- •Child whose either parent has BMI greater than or equal to 27.5 kg/m
- •Child allergic or intolerant to any ingredient found in the study product.
- •Child who was delivered pre-term.
- •Child was born small for gestational
- •Child had birth weight < 2500 g or > 4000 g.
- •Child has current acute or chronic infections.
- •Child demonstrates presence of severe gastrointestinal disorders.
- •Child has a diagnosis of neoplastic diseases, renal, hepatic and cardiovascular diseases.
- •Child has a diagnosis of hormonal or metabolic disorders.
- •Child has a congenital disease or genetic disorder.
- •Child is diagnosed with infantile anorexia nervosa.
- •Child has a developmental disability or physical disorder.
- •Child has disorders of hemoglobin structure, function or synthesis.
- •Child is participating in another study that has not been approved as a concomitant study.
结局指标
主要结局
Compliance with recommendation of a nutritional supplement consumption
时间窗: 48 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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