NCT02125123终止不适用
Oral Nutritional Supplementation in Children With Picky Eating Behaviors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 4
- 主要终点
- Vitamin D Intake
研究概览
简要总结
This study will investigate the effect of an oral nutritional supplement (ONS) along with dietary counseling on improving the dietary intake among children with picky eating behaviors.
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
- 36 Months 至 109 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 36 months and < 109 months of age.
- •Healthy and not suffering from any physical disability.
- •Height-for-age and BMI-for-age between the 5th and the 95th percentile; weight-for-age between the 5th and the 85th percentile.
- •Capable of oral feeding.
- •Has a mean score of greater than 3.0 on the fussiness category in the Children's Eating Behaviour Questionnaire and also consumes on average less than the daily recommendations for at least 3 of 5 food groups (Dietary Guidelines for America, 2010).
- •Willing to abstain from consuming non-study nutritional supplements during the study intervention period.
排除标准
- •History of an acute or chronic condition that may affect feeding habits or nutritional status.
- •Taking any medications or nutritional supplements on a daily basis for more than 2 weeks during the past month that may profoundly affect feeding habits or nutritional status.
- •Clinically significant nutritional deficiency requiring specific treatment with any other nutritional supplement.
- •Any acute/chronic condition requiring medical treatment which may include hospitalization.
- •Allergy or intolerance to any ingredient in the study product.
- •Gastrointestinal infection, acute constipation or acute diarrhea.
- •Hepatitis B or C, or HIV, or malignancy.
- •Congenital cardiac defects.
- •Dysphagia, aspiration risk or difficulty in swallowing due to acquired/congenital abnormalities.
- •Parent(s)/LG of the subject has any clinically significant medical disease or physical/psychological condition that may interfere with protocol adherence or ability of the parent(s)/LG to give informed consent.
结局指标
主要结局
Vitamin D Intake
时间窗: Change from Baseline to Week 4
次要结局
- Micronutrient Intake(Change from Baseline to Week 4)
- Macronutrient Intake(Change from Baseline to Week 4)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
不适用
Effect of Oral Nutritional Supplementation Combined With Impedance VectorsChronic Kidney Disease Requiring Chronic DialysisOverhydrationUndernutritionNCT05288101Universidad Autonoma de Queretaro39
已完成
不适用
Effects of Oral Nutrition Supplements in Children With Disease Associated UnderweightDisease Associated UnderweightNCT02383329Dr. Michael Chourdakis224
已完成
不适用
A Study of an Oral Nutrition Supplement (ONS) in Children.GrowthNCT02056275Abbott Nutrition256
已完成
2 期
Oral Nutritional Supplementation in Picky Eating ChildrenChildren - MalnutritionNCT02523027Abbott Nutrition321
已完成
3 期
A study of an oral nutrition supplement (ONS) in childreCTRI/2014/07/004717Abbott Nutrition International India256