Study the Efficiency of Oral Nutritional Supplementation on Anthropometric Indicators, Nutrition Status, Digestive Disorders, Anorexic and Upper Respiratory Infections in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Change of anthropometric indicators and nutrient status (wasting)
研究概览
简要总结
Evaluating the efficiency of using the nutrient production toward nutrition status (anthropometric index, the prevalence of wasting), digestive disorders, anorexia, and upper respiratory infections in children aged 24 - 71 months.
详细描述
The research involves a randomized controlled clinical trial (RCT), the plan is expected to conduct from 2022 to 2023 with over 600 children aged 24-71 months. The nutritional product produces a high amount of energy that provides over 468 kcal/100g; 12,5g/100g of protein; 12,5/100 of fat; 59,5g/100g of carbohydrate 1000ng/100g of IgG (immunoglobulin G) Colostrum; 15,3mg/100g of 2'FL HMO (health maintenance organization); 160mg/100g of MCT(Medium chain triglycerides) ; 3,7mg/100g of FOS(Fructo-Oligosaccharide) /Inulin; 810mg/100g of Lysine; 525mg/100g of Calcium; 55,6mg/100g of Magnesium; 5,6mg/100g of Iron; 3mg/100g of Zinc; 35,7µg/100g of Manganese; 8,1µg/100g of Selenium; 1290IU/100g of Vitamin A; 220 IU/100g of Vitamin D3; 33,1µg/100g of Vitamin K1; 510µg/100g of Vitamin B1; 700µg/100g of Vitamin B2; 360µg/100g of Vitamin B6; 1,4µg/100g Vitamin B12; 3120µg/100g of Acid Pantothenic; 62,7µg/100g of Acid Folic. 90 grams of the product which equals 2 packs (210ml x 2 per day) will supply about 33,0% - 43,6% of the required energy for children aged 2-5 years. Other 25 micronutrients and minerals include some essential vitamins such as Calcium 78,8 - 94,5 % RDAs, Iron 91-93% RDAs(recommended daily allowances), Vitamin A 86-103,2% RDAs, Zinc 56-66% RDAs, Vitamin D3 33% RDAs, Selenium 37-43% RDAs, Vitamin K1 43-50% RDAs, Folic Acid 38-56% RDAs. With other elements such as 2'FL HMO (15,3 mg), FOS/inulin (3700 mg), Choline ( 28 mg, Taurin 15,5 mg) ,colostrum IgG 24 1000mg. The study will be conducted at schools and homes: 600 children erratically divided into 2 groups, 1 group will use the product for 3 months (with the amount of use: twice per day, 45,0 grams 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 efficiency of nutritional products toward nutrition status ( anthropometric index, the prevalence of wasting), digestive disorders, anorexia, and upper respiratory infections in children aged 24-71 months.
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 (300 participants): Children eat usual dietary(not using nutrient products) for 3 months. After that, they will use the product.
Intervention Group (300 participants): Children eat usual dietary, but with 2 glasses of the nutrient product as the side meals. The product provides L-lysin, IgG 24h Colostrum, Calcium, Probiotics, HMO, DHA(Docosa Hexaenoic Acid), and Taurine within 3 months of use.
入排标准
- 年龄范围
- 24 Months 至 71 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between the age of 24 - 71 months old that currently study in 10 preschools in the area of 10 selected communes.
- •The family volunteered for the child to participate in the study
- •Currently residing at 10 selected communes (over 1 year of residing)
- •Z-score WHZ/BAZ < - 0.5
排除标准
- •Lactose intolerance
- •Children with a history of allergies, congenital diseases
- •Intellectual disability or are suffering from acute and chronic infectious diseases
研究组 & 干预措施
Usual Diet
(n=300): Children eat usual dietary (not using nutrient products) for 3 months. After that, they will use the products
Colos Gain Dietary Supplement
(n=300): Children eat usual dietary, but with 2 glasses of the nutrient product as the side meals. The product provides GOS(Galactooligosaccharides), Calcium, Probiotics, HMO, DHA, and Taurine within 3 months of use.
干预措施: Colos Gain (Dietary Supplement)
结局指标
主要结局
Change of anthropometric indicators and nutrient status (wasting)
时间窗: Up to 3 months of intervention
Children in the intervention group will improve more with the anthropometric indicators (weight, height) than children in the control group. 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. The nutrient status will be measure base on the changes in weight and height, also on
Change of digestive disorders, anorexia nervosa, and upper respiratory infections
时间窗: From date of using the product until the date of first documented improvement, assessed up to 3 months
Children in the intervention group improved more in digestive disorders, anorexia, and upper respiratory infections than in the control group. The changes in digestive disorders would illustrate in children defecating activities
次要结局
- Change of height for age Z-score(over 1 and 3 months)
- Change of weight for height Z-score(over 1 and 3 months)
- Body Mass Index, i.e. changes of Body Mass Index (BMI)(over 1 and 3 months)
- Change of weight for age Z-score(over 1 and 3 months)
- Changes in the percentage of children have anorexia, upper respiratory infections or gastrointestinal diseases(over 1 and 3 months)
研究者
Tu Nguyen Song
Head of Division Planning
National Institute of Nutrition, Vietnam