Improvement of Nutrition Status, Digestive Conditions, and Upper Respiratory Infections by Using Oral Nutritional Supplementation on Children in Vietnam

Malnutrition Clinical Trial

Official title:

Study the Efficiency of Oral Nutritional Supplementation on Anthropometric Indicators, Nutrition Status, Digestive Disorders, Anorexic and Upper Respiratory Infections in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05570045
• Other study ID #: COLOS-NIN
• Status: Completed
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: February 2024
• Source: National Institute of Nutrition, Vietnam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: August 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Months to 71 Months

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Lactose intolerance
• Children with a history of allergies, congenital diseases
• Intellectual disability or are suffering from acute and chronic infectious diseases

Related Conditions & MeSH terms

• Cachexia
• Infections
• Malnourished
• Malnutrition
• Respiratory Tract Infections
• Undernutrition
• Wasting

Intervention

Dietary Supplement:
• Colos Gain
Dietary Supplement: Colos Gain Colos Gain is a nutrient product made by VITADAIRY Dairy Joint Stock Company. Condition: Powder Color: White to light yellow Scent: The fresh scent of milk, gracious sugary smell. Date of use: 24 months from the manufactured date. Direction: Mix 5 spoons of Colos Gain (equal to 45 grams) with 180 ml of warm water (50°C) which provides 210kcal (The energy density reaches 1kal/ml). Consume 2-3 glasses per day or follow the directions from the medical supervisors. The product should consume less than 1 hour. Do not let the child eat the leftovers of the previous meal. Preserve: Store in a clean, dry place, and keep away from direct sunlight. Opened can or package must be closed and used up within 3 weeks.

Locations

Country	Name	City	State
Vietnam	Yen Bai Province Obstetrics and Children's Hospital	Yen Bai

Sponsors (1)

Lead Sponsor	Collaborator
Tu Nguyen Song

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in the percentage of wasted and malnutrition children	Changes in the risk of wasting and malnutrition after 1, 2, and 3 months of intervention. Data were entered using Epidata 3.1 software. Data analysis using the software called SPSS 18.0. Anthropometric data were processed using Anthro software from WHO, 2006. Statistics were used to analyze the data of the squared test (?2-test) and Fisher's exact test to compare the difference between the samples. ratio; Mc Nemar -test compares the difference in the percentage of malnutrition of each study group before and after the intervention. The rate of children got wasting and malnutrition will decrease as the body index increase over time. The measurement would be done by a TANITA scale and a wooden stadiometer.	over 1 and 3 months
Primary	Change of anthropometric indicators and nutrient status (wasting)	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	Up to 3 months of intervention
Primary	Change of digestive disorders, anorexia nervosa, and upper respiratory infections	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	From date of using the product until the date of first documented improvement, assessed up to 3 months
Secondary	Body Mass Index, i.e. changes of Body Mass Index (BMI)	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)	over 1 and 3 months
Secondary	Change of weight for age Z-score	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) , 2006	over 1 and 3 months
Secondary	Change of weight for height Z-score	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.	over 1 and 3 months
Secondary	Change of height for age Z-score	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, 2006	over 1 and 3 months
Secondary	Changes in the percentage of children have anorexia, upper respiratory infections or gastrointestinal diseases	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	over 1 and 3 months

External Links

•   Click here for more information about the organization in which this study is conducted. The Division of Planning is responsible to plan and implement the project.