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NCT Number: NCT06708546

Improvement of Nutrition, Digestion, and Respiration in Children in Vietnam Using Oral Nutritional Supplementation

Evaluating the effect of using Oral Nutritional Supplementation toward nutrition status, digestive disorders, upper respiratory disorders, and picky eating in children aged 24 - 59 months.

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Key information

Conditions

Undernutrition Behavior Body Weight Body Weight Changes Cachexia Feeding Behavior Food Fussiness Malnourished Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Thinness Wasting Weight Loss

Age range

24 month–59 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 effect of using Oral Nutritional Supplementation toward improving the nutritional status (anthropometric index, the prevalence of malnutrition) in children aged 24 - 59 months after four months of using the nutritional product.

Evaluating the effect of using Oral Nutritional Supplementation for digestive disorders (diarrhea and constipation), upper respiratory infection and picky eating in children aged 24 - 59 months.

The research involves a randomized controlled clinical trial (RCT), expected from 2023 to 2024 with 1000 children aged 24-59 months. The study will be conducted at schools and homes: 1000 children divided into 2 groups. One group will use the product for 4 months ( with the amount of use: twice per day, 180ml 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 effect of nutritional products toward nutritional status ( anthropometric index, the prevalence of micronutrients), digestive disorders, and picky eating in children aged 24-59 months.

The nutritional product produces a high amount of energy that provides ≥ 380 kcal/360 ml; 2 bottles equal to 180ml x 2 times/day will provide 28-37,3% energy requirement for children aged 2-4 years old. The product includes fat composition which provides 38-44% energy requirement including 1899 mg medium chain triglyceride (MCT), α Linolenic Acid, Linoleic Acid and 26 types of micronutrients and minerals including some essential micronutrients such as Calcium 110- 130% recommended nutrition needs (RNNs), Iron 58-59,3% RNNs, Vitamin A 91-110% RNNs, Zinc 25-28,9% RNNs, Vitamin D3 54% RNNs, Selen 66-77,6% RNNs, Vitamin K1 27-31,7% RNNs, Folic Acid 72-108% RNNs. Including other compositions such as 2'FL HMO (74 mg), Choline (79mg), Taurine (31,2mg)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children between the ages of 24 and 59 months old live in 6 selected communes in Yen Bai province.
  • The family volunteered for the child to participate in the study
  • Z-score height for age <-1 and Z-score weight for height <1
  • Participated in the screening and met the selection criteria

Exclusion criteria

  • Lactose intolerance
  • Intellectual disability or suffering from acute and chronic infectious diseases.
  • Z-score height for age, Z-score weight for height and Z-score weight for age <-4
  • Planing to move out of the selected trials areas in next 6 months

Treatment and study plan

Dielac Grow Plus

Dietary Supplement

Dialac Grow Plus is an Oral Nutritional Supplementation made by Vietnam Dairy Products Joint Stock Company - Vinamilk.

Condition: Liquid

Color: White

Date of use: 8 months from the manufactured date.

Preserve: Store in a clean, dry place, and avoid direct sunlight.

Primary outcomes

  1. Change of anthropometric indicators

    Time frame: After 4 months of intervention

    Children in the intervention group will improve more with the anthropometric indicators (weight, height) than children in the control group.

    This includes weight and height. 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.

  2. Change of digestive conditions

    Time frame: After 4 months of intervention

    Children in the intervention group will improve more with digestive conditions includes diarrhea, constipation, respiratory infection and picky eating than children in the control group

  3. Change in micronutrients status

    Time frame: After 4 months of intervention

    Children in the intervention group will improve more with the micronutrient status, including the Hb and serum zinc concentrations in blood, than children in the control group.

Secondary outcomes

  1. Change of weight for age Z-score

    Time frame: After 4 months of intervention

    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

  2. Change of weight for height Z-score

    Time frame: After 4 months of intervention

    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.

  3. Change of height for age Z-score

    Time frame: After 4 months of intervention

    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

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

    Time frame: After 4 months of intervention

    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. Assessment of Caregivers' Perceptions on the Safety and Effectiveness of the Product in Yen Bai

    Time frame: After 4 months of intervention

    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

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 - 59 Months Old.

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Nov 27, 2024
Registry last updated
Nov 27, 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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