Clinical trial NCT06708546: Improvement of Nutrition, Digestion, and Respiration in Children in Vietnam Using Oral Nutritional Supplementation
Official title: Study the Efficiency of Oral Nutritional Supplementation on Nutrition Status, Digestive Disorders, Respiratory Infection and Anorexic in Children Between 24 - 59 Months Old.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Undernutrition
Wasting
Malnourished
Keywords: Picky eating
Children
Digestive condition
Respiratory condition
Wasting
Nutrient status
Lead sponsor: National Institute of Nutrition, Vietnam
Sponsor class: OTHER_GOV
First posted: 2024-11-27
Enrollment: 981
Sex: ALL
Minimum age (years): 24
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Step 1: Investigate the nutritional status of all children aged 24 - 59 months in 6 selected communes in Yen Bai province. Expecting 2000 participants in 6 examined communes.

Step 2: After the investigative selection, participants that meet the standard will be invited to the study ( the selected communes can be narrowed if the targets are met). The study will move to the next step when parents sign the consent paper.

Step 3: Groups will be divided to investigate activities. Creating a list for all participants that meet the criteria, with Z-score height for age \<-1 and Z-score weight for height\<1. Random selection based on age ensures no significant difference in the nutritional index or related indicators in the group to assess the effectiveness of the intervention (divided by class/age). Then, randomly divided the target by class into two large groups (500 targets per group)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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)

Eligibility criteria: 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

Primary outcomes:
measure: Change of anthropometric indicators
timeFrame: After 4 months of intervention
measure: Change of digestive conditions
timeFrame: After 4 months of intervention
measure: Change in micronutrients status
timeFrame: After 4 months of intervention
Secondary outcomes:
measure: Change of weight for age Z-score
timeFrame: After 4 months of intervention
measure: Change of weight for height Z-score
timeFrame: After 4 months of intervention
measure: Change of height for age Z-score
timeFrame: After 4 months of intervention
measure: Changes in the percentage of children have anorexia, upper respiratory infections or gastrointestinal diseases
timeFrame: After 4 months of intervention
Other outcomes:
measure: Assessment of Caregivers' Perceptions on the Safety and Effectiveness of the Product in Yen Bai
timeFrame: After 4 months of intervention
Locations:
city: Yen Bai
country: Vietnam
facility: Yen Bai Province Obstetrics and Children's Hospital
Study officials:
affiliation: National Institute of Nutrition, Vietnam
name: Division of Planning National Institute of Nutrition
role: PRINCIPAL_INVESTIGATOR
References: