NCT05437068撤回不适用
Effects of Oral Nutritional Supplementation in 12-71 Months Old Children at Risk of Undernutrition
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Height-for-age-Z-score
研究概览
简要总结
This is a prospective, multicenter, single-arm intervention study. The expected duration of study participation for each participant is approximately 120 days. The current study aims to investigate the effectiveness of an ONS formula in children at risk or with undernutrition in Thailand.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child is between 1 year 0 days to 5 years 364 days old at enrolment
- •Undernourished or at risk of undernutrition, defined as:
- •WHZ <- 1 and HAZ <-1 for children up to 4 years 364 days, according to the WHO Growth Standards; or
- •BMIAZ <-1 and HAZ <-1 for children 5 years 0 days and older, according to the WHO Growth Reference Standards
- •Child is not currently breastfed
- •Child's parent(s)/LG is willing to abstain from giving additional non-study Oral Nutritional Supplement (ONS) other than the study product during the study intervention period
- •Child is a singleton
- •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
- •Child 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 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 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:
- •Severe gastrointestinal disorders such as celiac disease, short bowel syndrome, pancreatic insufficiency, or cystic fibrosis
- •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)
- •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
Height-for-age-Z-score
时间窗: Baseline to 120 days
Change in Height-for-age-Z-score
次要结局
- BMI-for-Age Measurement Calculations(Baseline to 30 days and 120 days)
- Weight(Baseline to 30 days and 120 days)
- Dietary Intake(Baseline to 30 days and 120 days)
- Appetite(Baseline to 30 days and 120 days)
- Weight-for-Height Measurement Calculations(Baseline to 30 days and 120 days)
- Physical Activity(Baseline to 30 days and120 days)
- Weight-for-Age Measurement Calculations(Baseline to 30 days and 120 days)
- Height-for-Age Measurement Calculations(Baseline to 30 days and 120 days)
- Height(Baseline to 30 days and 120 days)
- Mid-Upper-Arm Circumference (MUAC)(Baseline to 30 days and 120 days)
- MUAC-for-Age Measurement Calculations(Baseline to 30 days and 120 days)
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