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

Study the Efficiency of Oral Nutritional Supplementation on Nutrition Status, Digestive Disorders, Respiratory Infection and Anorexic in Children Between 24 - 59 Months Old.

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.

Study Overview

• Status: Completed
• Conditions: Wasting; Undernutrition; Malnourished
• Intervention / Treatment: Dietary supplement: Dielac Grow Plus

Detailed Description

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)

• Study Type: Interventional
• Enrollment (Actual): 981
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Yen Bai, Vietnam, 33000
    • Yen Bai Province Obstetrics and Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; (n=490): children eating normally (not using Oral Nutritional Supplementation) during 4 months of intervention. After the end, the product will be used for the following 4 months.
Experimental: Intervention group; (n=491): Children eating normally, with 2 boxes of Oral Nutritional Supplementation (180 ml x 2 times/day) as a snack meal. The product will be provided for subjects at school 7 days per week (From Monday to Sunday) and at home or school. Children use Oral Nutritional Supplementation twice per day, the first time at 9 am, and the second at 3 pm.	Dietary supplement: Dielac Grow Plus; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of anthropometric indicators	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.	After 4 months of intervention
Change of digestive conditions	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	After 4 months of intervention
Change in micronutrients status	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.	After 4 months of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	After 4 months of intervention
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.	After 4 months of intervention
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	After 4 months of intervention
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	After 4 months of intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Caregivers' Perceptions on the Safety and Effectiveness of the Product in Yen Bai	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	After 4 months of intervention

Collaborators and Investigators

• Sponsor: Tu Nguyen Song
• Investigators: Principal Investigator: Division of Planning National Institute of Nutrition, National Institute of Nutrition, Vietnam

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: July 5, 2023
• First Submitted That Met QC Criteria: November 25, 2024
• First Posted (Estimated): November 27, 2024

Study Record Updates

• Last Update Posted (Estimated): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Children; Wasting; Picky eating; Nutrient status; Digestive condition; Respiratory condition
• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Body Weight; Body Weight Changes; Weight Loss; Thinness; Malnutrition; Wasting Syndrome; Cachexia
• Other Study ID Numbers: DIELACGROW-NIN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No