NCT05161000已完成不适用
Effects of Oral Nutritional Supplementation With Dietary Counseling in Children at Risk of Undernutrition
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 279
- 试验地点
- 34
- 主要终点
- Weight-for-age z-score (WAZ)
研究概览
简要总结
The objective of this randomized, controlled trial is to evaluate the effects of consuming a pediatric oral nutritional supplement (ONS) plus dietary counseling for 120 days on anthropometric growth, strength, and nutritional status, compared with dietary counseling alone in undernourished children in the United States.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 36 Months 至 107 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child is 36 months - 107 months of age.
- •Child is undernourished as determined by BMI for age z-score or Mid-upper-arm circumference z-score
- •Child's caregiver has voluntarily signed and dated an informed consent form (ICF), approved by an IRB, and provided Health Insurance Portability and Accountability Act (HIPAA) or other applicable privacy regulation authorization prior to any participation in the study.
- •Child's caregiver is willing to abstain from providing non-study oral nutrition supplements during the study period duration.
- •Child's caregiver is able and willing to follow study procedures and record data in parent diaries and complete any forms or assessments needed during the study.
- •Child is willing to consume the study product for the duration of the study, if randomized to intervention group
排除标准
- •Child has a height-for-age z-score ≥
- •Child is currently drinking an oral nutritional supplement (ONS) on a regular basis (≥ 15 days in the past month)
- •Child is participating in another study that has not been approved as a concomitant study by AN.
- •Child has been diagnosed with the following:
- •Galactosemia, or an allergy or intolerance to any ingredient found in the study product
- •Acute or chronic infections including but not restricted to respiratory infections, diarrhea, Hepatitis B or C, HIV infection or tuberculosis
- •Severe gastrointestinal disorders such as celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis
- •Neoplastic, renal, hepatic or cardiovascular, hormonal or metabolic disorders, Down's syndrome or significant, uncorrected cardiac anomalies that may impact growth
- •Infantile anorexia nervosa, developmental disability, including physical disorders such as cerebral palsy, or a developmental delay that is considered too severe for participation
- •Disorders of hemoglobin structure, function or synthesis
- •Clinically significant nutritional deficiency requiring specialty nutritional therapy
- •Any other clinically significant medical condition, which in the investigator's opinion, makes him or her unsuitable for inclusion in the study.
结局指标
主要结局
Weight-for-age z-score (WAZ)
时间窗: baseline to 120 days
Change in weight-for-age z-score
次要结局
- Appetite(baseline to 120 days)
- Mid-upper-arm circumference (MUAC)(baseline to 120 days)
- Height(baseline to 120 days)
- Dietary Diversity(baseline to 120 days)
- Anthropometric Measurement Calculations(baseline to 120 days)
- Weight(baseline to 120 days)
研究者
研究点 (34)
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