NCT06708546

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 981 (actual)
• Sponsor: Tu Nguyen Song · Other Government
• Sex: All
• Age: 24 Months – 59 Months
• Healthy volunteers: Not accepted

Summary

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.

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)

Conditions

• Undernutrition
• Wasting
• Malnourished

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-04-01
• Primary completion: 2023-06-01
• Completion: 2024-02-01
• First posted: 2024-11-27
• Last updated: 2024-11-27

Locations

1 site across 1 country: Vietnam