Skip to main content
OpenTrials
Completed

NCT Number: NCT05551637

Evaluating Oral Nutritional Supplements on Children's Nutritional Status and Digestive Health in Vietnam.

Evaluating the efficiency of using Oral Nutritional Supplementation toward nutrition status (anthropometric index, the prevalence of wasting), digestive disorders, and anorexic in children aged 24 - 71 months.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Undernutrition Anorexia Body Weight Body Weight Changes Cachexia Malnourished Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Thinness Wasting 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

Evaluating the efficiency of using Oral Nutritional Supplementation toward the improvement of the anthropometric index (weight, height, weight for age Z-score, height for age Z-score, and weight for height Z-score ), nutrition status (the prevalence of wasting) in children aged 24 - 71 months after 3 months using the nutrient product.

Evaluating the efficiency of using Oral Nutritional Supplementation for digestive disorders and anorexic in children aged 24 - 71 months.

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 nutrient product produces a high amount of energy that provides over 472kcal/100g; 15,6g/100g of protein; 20,8g/100 of fat; 55,6g/100g of carbonhydrate; 338mg/100g of alpha-Linolenic acid; 1800mg/100g of Linoleic acid; 19,7mg/100g of 2'FL HMO; 1088mg/100g of MCT; 2700mg/100g of FOS/Inulin; 55mg/100g of GOS; 1000mg/100g of Lysine; 687mg/100g of Calcium; 68mg/100g of Magnesium; 6,5mg/100g of Iron; 3,6/100g of Zinc; 41,9µg/100g of Manganese; 2176IU/100g of Vitamin A; 376 IU/100g of Vitamin D3; 44µg/100g of Vitamin K1; 820µg/100g of Vitamin B1; 900µg/100g of Vitamin B2; 610µg/100g of Vitamin B6; 1,92µg/100g Vitamin B12; 4140µg/100g of Acid Pantothenic; 115µg/100g of Acid Folic; 98,2 grams of the product, which equals 2 packs (230ml x 2 per day) will supply about 36,4% - 48,1% of the required energy for children aged 2-5 years old. Additional components include Alpha-Linolenic Acid, which provides 67% of the recommended dietary allowances (RDAs), Linolenic Acid 60, which provides 90% RDAs, and 25 other micronutrients and minerals that include some essential vitamins such as Calcium 112-114% RDAs, Iron 118-120.4% RDAs, Vitamin A 145-174% RDAs, Zinc 75-87% RDAs, Vitamin D3 62% RDAs, Seleni 53-63% RDAs, Vitamin K 63-73% RDAs, Folic Acid 76-115% RDAs. With other elements such as 2'FL HMO (19,7 mg), FOS/inulin (2700 mg), Choline ( 47 mg, Taurine 20 mg) , multi medium-chain triglyceride (MCT) (1088 mg), Bifidobacterium longum (109 CFU). 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, 49,2 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 nutrient products toward nutrition status ( anthropometric index, the prevalence of wasting), digestive disorders, and anorexic 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

Kazu Gain Gold

Dietary Supplement

Kazu Gain Gold is an Oral Nutritional Supplementation made by AIWAIDO Food 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.

User Manual: Mix 6 spoons of Kazu Gain Gold (equal to 49,2 grams) with 180 ml of warm water (The energy density reaches 1kal/ml). Consume 2 glasses per day or follow the directions from the medical staff. 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. Improvement of Digestive Disorders and Anorexia Nervosa

    Time frame: From date of using the product until the date of first documented improvement, assessed up to 3 months

    Children in intervention group will have more improvement in the digestive disorders and anorexic than children control group

  2. Change in Weight (kg)

    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 centre of the scale. When the balance is stable, read and write the result in kg and an odd number after the comma.

    All data will be measured at the time T0 (at baseline) and T3 (after 3 months)

  3. Change of Weight for Age Z-score

    Time frame: over 1 and 3 months

    Change of average weight for age Z Score using the World's Health Organization (WHO) software Anthro and WHO AnthroPlus. Moreover, compare the difference between before intervention and after the intervention. A Z-score of 0 represents the population median. The standard deviations above the median represent a better outcome and vice versa.

  4. Change of Weight for Height Z-score

    Time frame: over 1 and 3 months

    Change of average weight for height Z Score using WHO Anthro and WHO AnthroPlus. Moreover, compare the difference between before intervention and after the intervention. A Z-score of 0 represents the population median. The standard deviations above the median represent a better outcome and vice versa.

  5. Change in Height (cm)

    Time frame: over 1 and 3 months

    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 cm and an odd number after the comma.

    All data will be measured at the time T0 (at baseline) and T3 (after 3 months)

  6. Change of Height for Age Z-score

    Time frame: over 1 and 3 months

    Change of average height for age Z Score using WHO Anthro and WHO AnthroPlus. Moreover, compare the difference between before intervention and after the intervention. A Z-score of 0 represents the population median. The standard deviations above the median represent a better outcome and vice versa.

Secondary outcomes

  1. Changes in the Rate of Children Have Gastrointestinal Diseases

    Time frame: over 1 and 3 months

    Changes in the percentage of anorexia, the incidence of gastrointestinal diseases (diarrhea, constipation) after intervention

  2. Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting

    Time frame: over 1 and 3 months

    Changes in the rate of malnutrition and risk of underweight, wasting and stunting after 1, 2 and 3 months of intervention

Sponsors and collaborators

Lead sponsor

Tu Nguyen Song

Other Gov

Registry information

Official study title

Study the Efficiency of Oral Nutritional Supplementation on Nutrition Status, Digestive Disorders, Respiratory Infection and Anorexic in Children Between 24 - 71 Months Old.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 22, 2022
Registry last updated
Jan 14, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.