Study the Efficiency of Oral Nutritional Supplementation on Nutrition Status, Digestive Disorders, Respiratory Infection and Anorexic in Children Between 24 - 59 Months Old.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 981
- 试验地点
- 2
- 主要终点
- Change of anthropometric indicators
研究概览
简要总结
Evaluating the effect of using Oral Nutritional Supplementation toward nutrition status, digestive disorders, upper respiratory disorders, and picky eating in children aged 24 - 59 months.
详细描述
Evaluating the effect of using Oral Nutritional Supplementation toward improving the nutritional status (anthropometric index, the prevalence of malnutrition) in children aged 24 - 59 months after four months of using the nutritional product.
Evaluating the effect of using Oral Nutritional Supplementation for digestive disorders (diarrhea and constipation), upper respiratory infection and picky eating in children aged 24 - 59 months.
The research involves a randomized controlled clinical trial (RCT), expected from 2023 to 2024 with 1000 children aged 24-59 months. The study will be conducted at schools and homes: 1000 children divided into 2 groups. One group will use the product for 4 months ( with the amount of use: twice per day, 180ml each time). The product will be distributed to the students through the schools. Monitoring will be performed carefully by the commune and district Health Department and the Centers for Disease Control and Prevention weekly. The study aims to evaluate the effect of nutritional products toward nutritional status ( anthropometric index, the prevalence of micronutrients), digestive disorders, and picky eating in children aged 24-59 months.
The nutritional product produces a high amount of energy that provides ≥ 380 kcal/360 ml; 2 bottles equal to 180ml x 2 times/day will provide 28-37,3% energy requirement for children aged 2-4 years old. The product includes fat composition which provides 38-44% energy requirement including 1899 mg medium chain triglyceride (MCT), α Linolenic Acid, Linoleic Acid and 26 types of micronutrients and minerals including some essential micronutrients such as Calcium 110- 130% recommended nutrition needs (RNNs), Iron 58-59,3% RNNs, Vitamin A 91-110% RNNs, Zinc 25-28,9% RNNs, Vitamin D3 54% RNNs, Selen 66-77,6% RNNs, Vitamin K1 27-31,7% RNNs, Folic Acid 72-108% RNNs. Including other compositions such as 2'FL HMO (74 mg), Choline (79mg), Taurine (31,2mg)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
盲法说明
Control Group (490 participants): children eating normally (not using Oral Nutritional Supplementation) during 4 months of intervention. After the end, the product will be used for the following 4 months.
Intervention Group (491 participants): children eating normally, with 2 boxes of Oral Nutritional Supplementation (180ml each) as a snack meal. The product provides 9,5% milk powder, milk fat and 26 micronutrients and provides FOS, HMO, DHA, and Taurine within 4 months of use.
入排标准
- 年龄范围
- 24 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between the ages of 24 and 59 months old live in 6 selected communes in Yen Bai province.
- •The family volunteered for the child to participate in the study
- •Z-score height for age <-1 and Z-score weight for height <1
- •Participated in the screening and met the selection criteria
排除标准
- •Lactose intolerance
- •Intellectual disability or suffering from acute and chronic infectious diseases.
- •Z-score height for age, Z-score weight for height and Z-score weight for age <-4
- •Planing to move out of the selected trials areas in next 6 months
结局指标
主要结局
Change of anthropometric indicators
时间窗: After 4 months of intervention
Children in the intervention group will improve more with the anthropometric indicators (weight, height) than children in the control group. This includes weight and height. Weight is measured in kg with one decimal value by the Body composition analyzer called the TANITA scale. Children wear light clothes while measuring. A wooden stadiometer measures height by precisely 0.1cm.
Change of digestive conditions
时间窗: After 4 months of intervention
Children in the intervention group will improve more with digestive conditions includes diarrhea, constipation, respiratory infection and picky eating than children in the control group
Change in micronutrients status
时间窗: After 4 months of intervention
Children in the intervention group will improve more with the micronutrient status, including the Hb and serum zinc concentrations in blood, than children in the control group.
次要结局
- Change of weight for age Z-score(After 4 months of intervention)
- Change of weight for height Z-score(After 4 months of intervention)
- Change of height for age Z-score(After 4 months of intervention)
- Changes in the percentage of children have anorexia, upper respiratory infections or gastrointestinal diseases(After 4 months of intervention)
研究者
Tu Nguyen Song
Head of Division Planning
National Institute of Nutrition, Vietnam