NCT02523027已完成2 期
Oral Nutritional Supplementation in Picky Eating Children
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 321
- 试验地点
- 22
- 主要终点
- Change in WHO weight-for-height percentile
研究概览
简要总结
This study will investigate the effect of two oral nutritional supplements (ONS) along with dietary counseling vs dietary counseling alone on growth among picky eating children from India, aged > 24 months to ≤ 48 months over a period of 90 days.
详细描述
Study Objective:
To investigate the effect of two oral nutritional supplements (ONS) along with dietary counseling vs dietary counseling alone on growth among picky eating children from India, aged > 24 months to ≤ 48 months over a period of 90 days.
Number of Subjects / Length of Participation:
Approximately 321 subjects (107 subjects per group) will be enrolled from estimated 8-10 study centers to obtain at least 255 evaluable subjects (85 subjects per group), assuming 20% attrition rate. Expected total duration for the study is approximately 12 months.
Study Design :
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child is > 24 months and ≤ 48 months of age at visit
- •Child of either gender (Male and Female).
- •Child has a weight-for-height between 3rd - 15th percentiles according to current WHO Growth Charts at visit
- •(WHO Growth Chart 2007)
- •Child is a picky eater, defined as meeting at least two of the following criteria. A child, who:
- •eats only a limited number of foods
- •is unwilling to try new foods
- •refuses to eat vegetables and/or foods from other food groups
- •shows strong food likes and dislikes
- •has behaviors that disrupt mealtime
- •Child is a habitual milk drinker at least 1 glass (approximately 200mL) of milk daily.
- •Child is able to consume foods and beverages orally.
- •Child's Legal Guardian (LG) or parent(s) is willing to abstain from giving additional non-study nutritional supplements including vitamin/mineral supplements, micronutrient fortified beverages, oral nutritional supplements other than the study product during the study intervention period.
- •Child's Legal Guardian (LG) or parent(s) has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) prior to any participation in the study.
- •Child's Legal Guardian (LG) or parent(s) is able and willing to follow study procedures and record data in parent diary and complete any forms or assessments needed throughout the study.
- •Child's Legal Guardian (LG) or parent(s)is not planning to relocate during the study period
排除标准
- •Child has been diagnosed with Lactose Intolerance & Galactosemia according to medical records or Legal Guardian (LG) /parent report.
- •Child has been diagnosed or is known to be allergic or intolerant to any ingredient found in the study product according to medical records or Legal Guardian (LG)/parent report.
- •Child has a current acute or chronic infection including respiratory infection, diarrhea, acute or chronic, Hepatitis B or C, HIV infection or tuberculosis according to medical records or Legal Guardian (LG)/parent report.
- •Child has been diagnosed with presence of severe gastrointestinal disorders including celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis according to medical records or Legal Guardian (LG)/parent report.
- •Child has been diagnosed with neoplastic, renal, hepatic or cardiovascular disease according to medical records or Legal Guardian (LG) /parent report.
- •Child has been diagnosed with hormonal or metabolic disorders according to medical records or Legal Guardian (LG) /parent report.
- •Child has been diagnosed with congenital disease or genetic disorders such as atrial or ventricular wall defects, or Down's syndrome according to medical records or Legal Guardian (LG) /parent report.
- •Child has been diagnosed with infantile anorexia nervosa according to medical records or Legal Guardian (LG) /parent report.
- •Child has been diagnosed with a developmental disability, including physical disorders such as cerebral palsy, or developmental delay according to medical records or Legal Guardian (LG) /parent report.
- •Child has been diagnosed with disorders of hemoglobin structure, function or synthesis according to medical records or Legal Guardian (LG) /parent report.
- •Child has a clinically significant nutritional deficiency requiring specific treatment with another nutritional supplement (other than the study product) as diagnosed by the investigator.
- •Child has any other clinically significant medical condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study.
研究组 & 干预措施
Experimental Group 1:
Experimental
Oral nutritional supplement (List No S691/Z0) and dietary counseling
干预措施: Oral nutritional supplement (List No S691/Z0) (Dietary Supplement)
Experimental Group 1:
Experimental
Oral nutritional supplement (List No S691/Z0) and dietary counseling
干预措施: Dietary Counselling (Other)
Experimental Group 2
Experimental
Oral nutritional supplement (List No- P968/Z0) and dietary counseling.
干预措施: Oral nutritional supplement (Dietary Supplement)
Experimental Group 2
Experimental
Oral nutritional supplement (List No- P968/Z0) and dietary counseling.
干预措施: Dietary Counselling (Other)
Control Group
No Intervention
Dietary Counselling only.
结局指标
主要结局
Change in WHO weight-for-height percentile
时间窗: Day 1 to Day 90
次要结局
- Change in weight-for-height WHO z-score and percentile(Day 1 to Day 90)
- Change in Mid Upper Arm Circumference-for-age WHO z-score and percentile(Day 1 to Day 90)
- Change in appetite score(Days 1, 7, 30, 60 and 90)
- Change in BMI-for-age WHO z-score and percentile(Day 1 to Day 90)
- Palatability scores for the oral nutritional supplements(Days 7, 30, 60 and 90)
- Change in weight-for-height WHO z-score(Day 1 to Day 90)
- Change in weight-for-age WHO z-score and percentile(Day 1 to Day 90)
- Average energy macronutrients (Carbohydrates, Fats, & Proteins) and micronutrients consumption via 24 hr dietary recall(Day 1, 7, 30, 60 and 90)
- Change in height-for-age WHO z-score and percentile(Day 1 to Day 90)
研究者
研究点 (22)
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