Improvement of Nutrition Status, Digestive Conditions, and Upper Respiratory Infections by Using Oral Nutritional Supplementation on Children in Vietnam
- Conditions
- UndernutritionMalnutritionWastingMalnourished
- Interventions
- Dietary Supplement: Colos Gain
- Registration Number
- NCT05570045
- Lead Sponsor
- Tu Nguyen Song
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
- 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
- Lactose intolerance
- Children with a history of allergies, congenital diseases
- Intellectual disability or are suffering from acute and chronic infectious diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Colos Gain Dietary Supplement Colos Gain (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.
- Primary Outcome Measures
Name Time Method Change of anthropometric indicators and nutrient status (wasting) 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 onChange of digestive disorders, anorexia nervosa, and upper respiratory infections 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
- Secondary Outcome Measures
Name Time Method Change of height for age Z-score over 1 and 3 months Change of average height for age Z Score and the difference between before intervention and after the intervention.
A wooden stadiometer measures height by precisely 0.1cm. Children stand up straight, their eyes look straight, and the top of their head touches the wooden shelf fixed at a 0 cm position. The child's whole body ensures that 9 points touch the surface of the ruler: occipital, shoulder blade, buttocks, calf, and heel. The result is recorded in centimeters and an odd number after the comma.
Age of the child is calculated by subtracting the date of birth from the census date, and classified according to WHO, 2006Change of weight for height Z-score over 1 and 3 months Change of average weight for height Z Score and the difference between before intervention and after the intervention.
Weight is measured in kg with one decimal value by the Body composition analyzer TANITA scale. The scale is checked and adjusted before use. Children wear light clothing, remove shoes and sandals, and sit or lie balanced, at the center of the scale. As soon as the balance is stable, read and write the result in kg and an odd number after the comma.
A wooden stadiometer measures height by precisely 0.1cm. Children stand up straight, their eyes look straight, and the top of their head touches the wooden shelf fixed at a 0 cm position. The child's whole body ensures that 9 points touch the surface of the ruler: occipital, shoulder blade, buttocks, calf, and heel. The result is recorded in centimeter and an odd number after the comma.Body Mass Index, i.e. changes of Body Mass Index (BMI) over 1 and 3 months Weight is measured in kg with one decimal value by the Body composition analyzer TANITA scale. The scale is checked and adjusted before use. Children wear light clothing, remove shoes and sandals, and sit or lie balanced, at the center of the scale. As soon as the balance is stable, read and write the result in kg and an odd number after the comma.
A wooden stadiometer measures height by precisely 0.1cm. Children stand up straight, their eyes look straight, and the top of their head touches the wooden shelf fixed at a 0 cm position. The child's whole body ensures that 9 points touch the surface of the ruler: occipital, shoulder blade, buttocks, calf, and heel. The result is recorded in centimeters and an odd number after the comma.
All data will be measured at the time T0 (at baseline) and T3 (after 3 months)Change of weight for age Z-score over 1 and 3 months Change of average weight for age Z Score and the difference between before intervention and after the intervention.
Weight is measured in kg with one decimal value by the Body composition analyzer TANITA scale. The scale is checked and adjusted before use. Children wear light clothing, remove shoes and sandals, and sit or lie balanced, at the center of the scale. As soon as the balance is stable, read and write the result in kg and an odd number after the comma.
Age of the child is calculated by subtracting the date of birth from the census date and classified according to WHO (World Health Organization) , 2006Changes in the percentage of children have anorexia, upper respiratory infections or gastrointestinal diseases over 1 and 3 months Changes in the percentage of anorexia, the percentage of gastrointestinal diseases (diarrhea, constipation), and anorexia above after intervention. The changes in digestive disorders would demonstrate in children defecating activities
Trial Locations
- Locations (1)
Yen Bai Province Obstetrics and Children's Hospital
🇻🇳Yen Bai, Vietnam