NCT02056275已完成不适用
A Study of an Oral Nutrition Supplement (ONS) in Children.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 8
- 主要终点
- Weight
研究概览
简要总结
To assess the effect of oral nutritional supplementation with dietary counseling versus dietary counseling alone on growth of preschool children over a period of 90 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 24 Months 至 72 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 24-72 months (inclusive), both genders.
- •Diagnosed with current acute upper respiratory tract infection.
- •Weight-for-age between 3rd - 15th percentile according to WHO Growth Charts.
- •Identified as a picky eater.
- •Able to consume foods and beverages orally.
- •Willing to abstain from additional non-study provided protein supplements or nutritional supplements throughout the study period.
排除标准
- •Current illness requiring hospitalization.
- •Gastrointestinal infection and/or acute diarrhea at the time of inclusion in the study.
- •Currently taking medication that could affect absorption/metabolism of study product or weight of the child.
- •Diagnosed with recurrent respiratory infections due to cystic fibrosis, immunodeficiency syndromes, and congenital abnormalities of the respiratory tract, congenital lung and ciliary abnormalities, an unsuspected foreign body and asthma.
- •Active tuberculosis, acute hepatitis B or C, or HIV, malignancy.
- •History of diabetes mellitus.
- •Received antibiotic therapy within the last two weeks before start of the study.
- •Dysphagia, aspiration risk, difficulty in swallowing due to acquired / congenital abnormalities that would hamper oral intake of the study product.
- •Clinically significant nutritional deficiency requiring specific treatment with any other nutritional supplement (not study product).
研究组 & 干预措施
ONS + dietary counseling
Experimental
ONS/day + dietary counseling
干预措施: Nutrition supplement + dietary counseling (Other)
Dietary counseling
Active Comparator
Dietary counseling
干预措施: Dietary Counseling (Other)
结局指标
主要结局
Weight
时间窗: Study Day (SD) 1 to 90
Change in weight-for-age from Day 1 to Day 90
次要结局
- Sick Days(Study Day (SD) 1 to 90)
- Dietary Intake(Study Day (SD) 1 to 90)
- Doctor Visits(Study Day (SD) 1 to 90)
- Respiratory Infections(Study Day (SD) 1 to 90)
- Appetite Score(Study Day (SD) 3, 10, 30, 60 and 90)
研究者
研究点 (8)
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