NCT05239208已完成不适用
Effects of Oral Nutritional Supplementation With Dietary Counseling in 24-60 Months Old 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
- 330
- 试验地点
- 2
- 主要终点
- Weight-for-Age Z-Score
研究概览
简要总结
This prospective, randomized, controlled study will evaluate the effects of oral nutritional supplementation plus dietary counseling versus dietary counseling alone in children at nutritional risk.
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
- 24 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 24-60 months old
- •Undernourished or at risk of undernutrition according to the WHO Growth Standards.
- •Child's parent(s)/legal guardian (LG) is willing to abstain from giving additional non-study ONS other than the study product during the study intervention period.
- •Child's parent(s)/LG 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 parent(s)/LG is not planning to relocate during the study period.
- •Child's parent(s)/LG has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) or other applicable privacy regulation authorization prior to any participation in the study.
排除标准
- •Participant participates in another study that has not been approved as a concomitant study.
- •Child is known to have galactosemia, be allergic or intolerant to any ingredient found in the study product.
- •Child is currently drinking an Abbott product(s).
- •Child had a history of preterm delivery, defined as a birth before 37 completed weeks of gestation as reported by parent(s)/LG.
- •Child had birth weight < 2500 g or > 4000 g.
- •Child whose either parent has BMI ≥ 27.5 kg/m2
- •Child has continuous oral nutrition supplement (ONS) usage for at least 15 days in the past 1 month prior to screening. The standard ONS formula usually has an energy density of at least 1 kcal/mL, containing protein, carbohydrate and/or fat, as well as a wide range of micronutrients to supplement or use as the sole source of nutrition.
- •Child has current acute or chronic infections including but not restricted to respiratory infections, diarrhea, acute and chronic Hepatitis B or C, HIV infection or tuberculosis.
- •Child has been diagnosed with the following according to medical records or report by parent(s)/LG or the clinician's judgment:
- •Severe gastrointestinal disorders such as celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic (Exception: Intestinal parasites infection)
- •Neoplastic, renal, hepatic or cardiovascular, hormonal or metabolic disorders, congenital disease or genetic disorders such as atrial or ventricular wall defects, Down's syndrome, or thalassemia
- •Infantile anorexia nervosa, developmental disability, including physical disorders such as cerebral palsy, or developmental delay
- •Disorders of hemoglobin structure, function or synthesis
- •Clinically significant nutritional deficiency requiring specific treatment with another nutritional supplement (other than the study product) as diagnosed by the investigator.
- •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
时间窗: Baseline to 120 Days
Change in weight-for-age z-score
次要结局
- Height(Baseline to 240 Days)
- Weight(Baseline to 240 Days)
- MUAMC Measurement Calculations(Baseline to 240 Days)
- Weight-for-Height Measurement Calculations(Baseline to 240 Days)
- Mid-Upper-Arm Circumference (MUAC)(Baseline to 240 Days)
- Dietary Intake(Baseline to 240 Days)
- BMI-for-Age Measurement Calculations(Baseline to 240 Days)
- Height-for-Age Measurement Calculations(Baseline to 240 Days)
- Appetite(Baseline to 240 Days)
研究者
研究点 (2)
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