The Effect of Standard Versus High Energy Density, Low Volume Oral Nutritional Supplements in Children Requiring Nutritional Support - a Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 主要终点
- Nutrient intake
研究概览
简要总结
This study is a pilot trial investigating the effects of a high energy drink for children, in comparison to standard energy drink for children.
详细描述
A four week, multi-centre, randomised controlled trial investigating the effects of a high energy density, low volume oral nutritional supplement versus standard energy density oral nutritional supplements in children aged 1-12yrs old requiring nutritional support. Fifty eligible children will be recruited and randomised to receive either the high energy density oral nutritional supplement or the standard energy density oral nutritional supplement for four weeks. The primary outcome is nutrient intake, with secondary outcomes of compliance, tolerance, acceptability, anthropometry and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Aged 1-12yrs
- •Faltering growth and/or requiring oral nutritional supplements to meet nutritional requirements
- •Expected to receive at least one bottle of the study product per day
- •Able to take study products orally during the study period
- •Written informed consent from parent/carer
排除标准
- •Requirement for 100% of their nutrition via enteral tube and/or parenteral feeding.
- •Children with major hepatic or renal dysfunction
- •Children with galactosaemia or severe lactose intolerance
- •Requirement for elemental or semi-elemental feeds
- •Investigator concern around willingness/ability of child/parent/carer to comply with protocol requirements
- •Participation in other studies within 2 weeks of study
结局指标
主要结局
Nutrient intake
时间窗: 4 weeks (28 days)
Dietary intake, including the intake of all foods and fluids, will be recorded and analysed throughout the study.
次要结局
- Tolerance: How well the child tolerates the oral nutritional supplements (including changes to gastrointestinal symptoms)(4 weeks (28 days))
- Compliance: Compliance with oral nutritional supplements in Group A and Group B; how much of the oral nutritional supplement is taken in comparison to the amount advised by the Dietitian.(4 weeks (28 days))
- Anthropometry(4 weeks (28 days))
- Acceptability: How acceptable the oral nutritional supplement is to the child and their parent/carer, including taste, texture, ease of use, etc.(4 weeks (28 days))
- Safety assessed by adverse events, to be recorded throughout study.(4 weeks (28 days))