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Completed

NCT Number: NCT05570045

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

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.

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Key information

Conditions

Wasting Anorexia Anorexia Nervosa Body Weight Body Weight Changes Cachexia Digestive System Diseases Feeding and Eating Disorders Infections Malnourished Malnutrition Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Digestive Thinness Undernutrition Weight Loss

Age range

24 month–71 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yen Bai Province Obstetrics and Children's Hospital

Yên Bái, 33000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colos Gain

Dietary Supplement

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.

Primary outcomes

  1. Change of anthropometric indicators and nutrient status (wasting)

    Time frame: 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

  2. Change of digestive disorders, anorexia nervosa, and upper respiratory infections

    Time frame: 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 outcomes

  1. Body Mass Index, i.e. changes of Body Mass Index (BMI)

    Time frame: 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)

  2. Change of weight for age Z-score

    Time frame: 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) , 2006

  3. Change of weight for height Z-score

    Time frame: 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.

  4. Change of height for age Z-score

    Time frame: 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, 2006

  5. Changes in the percentage of children have anorexia, upper respiratory infections or gastrointestinal diseases

    Time frame: 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

Other outcomes

  1. Changes in the percentage of wasted and malnutrition children

    Time frame: over 1 and 3 months

    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 (χ2-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.

Sponsors and collaborators

Lead sponsor

Tu Nguyen Song

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 6, 2022
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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