Clinical trial NCT05551637: Evaluating Oral Nutritional Supplements on Children's Nutritional Status and Digestive Health in Vietnam.
Official title: Study the Efficiency of Oral Nutritional Supplementation on Nutrition Status, Digestive Disorders, Respiratory Infection and Anorexic in Children Between 24 - 71 Months Old.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Undernutrition
Wasting
Malnourished
Keywords: Anorexic
Nutrition
Oral Nutritional Supplementation
Children
Digestive Condition
Nutrition Status
Wasting
Lead sponsor: National Institute of Nutrition, Vietnam
Sponsor class: OTHER_GOV
First posted: 2022-09-22
Enrollment: 600
Sex: ALL
Minimum age (years): 24
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Step 1: Investigate the nutrition status of all children aged 24 - 71 months in 10 preschools in 10 selected communes. Expecting 3500 targets in 10 examined preschools

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

Step 3: Groups will be divided to investigate activities. Creating a list for all participants that meet the criteria, with WHZ/BAZ \<-0,5. Randomly selection based on age to ensure that there is 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 three large groups (300 targets per group)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement of Digestive Disorders and Anorexia Nervosa
timeFrame: From date of using the product until the date of first documented improvement, assessed up to 3 months
measure: Change in Weight (kg)
timeFrame: over 1 and 3 months
measure: Change of Weight for Age Z-score
timeFrame: over 1 and 3 months
measure: Change of Weight for Height Z-score
timeFrame: over 1 and 3 months
measure: Change in Height (cm)
timeFrame: over 1 and 3 months
measure: Change of Height for Age Z-score
timeFrame: over 1 and 3 months
Secondary outcomes:
measure: Changes in the Rate of Children Have Gastrointestinal Diseases
timeFrame: over 1 and 3 months
measure: Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting
timeFrame: over 1 and 3 months
Other outcomes:
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: