CTRI/2023/04/051566进行中（未招募）不适用
Effect of an oral nutrition supplement on growth in Indian children in age group 3-6.9 years at nutritional risk: A prospective, randomized, open label, controlled, parallel study.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- 1.Change in height-for-age WHO percentile
研究概览
简要总结
The study is being conducted to evaluate the effect of an oral nutrition supplement on growth in Indian children in age group 3-6.9 years at nutritional risk. The study will investigate the effect of oral nutritional supplement (ONS) along with dietary counselling vs only dietary counselling on anthropometric growth parameters among preschool children from India, aged ≥ 3 to 6.9 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 3.00 Year(s) 至 6.90 Year(s)（—）
- 性别
- All
入选标准
- •A subject will be considered eligible for inclusion in this study only if ALL of the following criteria apply:
- •Subject (male or female) aged 3.0-6.9 years, and residing in India
- •Subject to remain in the same locality for the duration of the study (up to 6 months)
- •Subject has a Height for age less than 25th percentile according to current WHO Growth Charts (WHO Growth Chart 2007)
- •Subject has a weight for height less than 25th percentile according to current WHO Growth Charts (WHO Growth Chart 2007)
- •Subject is able to consume foods and beverages orally
- •Child is a picky eater, defined as meeting at least two of the following criteria.
- •A child, who a.
- •eats only a limited number of foods b.is unwilling to try new foods c.
- •refuses to eat vegetables and or foods from other food groups d.
- •shows strong food likes and dislikes 16 e.
- •has behaviors that disrupt mealtime
- •Child is a habitual milk drinker at least 1 glass (approx.
- •200ml) of milk daily.
- •Subject with good general and mental health in the investigator’s opinion
- •Subject’s parent or LAR understand and are willing, able and likely to comply with all study procedures and restrictions
- •Subject’s parent or LAR are willing to sign the ICF.
排除标准
- •Subject’s meeting any of the following criteria are not eligible for the study:
- •Subject has been diagnosed with Lactose Intolerance & Galactosemia according to medical records or parent or LAR report.
- •Subject has been diagnosed or is known to be allergic or intolerant to any ingredient found in the study product according to medical records or parent or LAR report.
- •Subject has been diagnosed with a developmental disability, including pathological reason for stunted & wasting, physical disorders such as cerebral palsy, or developmental delay according to medical records or parent or LAR report.
- •Subject with recent history (within 3 months prior to signing ICF) of surgery, serious infections or injuries
- •Subject who is immunocompromised (e.g. HIV infection, AIDS, congenital immunodeficiency) or has known congenital diseases or malformations (e.g. gastrointestinal malformations) or has a history of endocrine abnormality or has chronic illnesses or conditions (e.g. jaundice, asthma, diabetes, cancer, tuberculosis, diarrhea, etc) or medications (e.g. systemic corticosteroids) which could interfere with the study objectives
- •Subject who needs to be fed with a special diet OR who needs to be fed with a diet which is different from that advised by the study center nutritionist OR current taking a nutritional supplement (MVM with average consumption of greater than or equal to 10 percent) in the past 3 months prior to screening
- •Subject on restrictions that prevent adherence to the diet plan, which is advised by the study center nutritionist during dietary advice 17
- •Subject with known food allergies as reported by parent or LAR
- •Subject currently participating, or has participated in a drug or device study or a nutritional program run by the local government or NGO within a period of 30 days prior to screening.
结局指标
主要结局
1.Change in height-for-age WHO percentile
时间窗: at 6 months compared to baseline
次要结局
- 1.Change in height-for-age WHO percentile(2.Change in height-for-age WHO z-score)
研究者
研究点 (1)
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