Clinical trial NCT05570045: Improvement of Nutrition Status, Digestive Conditions, and Upper Respiratory Infections by Using Oral Nutritional Supplementation on Children in Vietnam
Official title: Study the Efficiency of Oral Nutritional Supplementation on Anthropometric Indicators, Nutrition Status, Digestive Disorders, Anorexic and Upper Respiratory Infections in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wasting
Undernutrition
Malnourished
Malnutrition
Keywords: children
oral nutrition supplementation
anorexic
anorexia nervosa
digestive disorders
upper respiratory infections
nutrition status
wasting
Lead sponsor: National Institute of Nutrition, Vietnam
Sponsor class: OTHER_GOV
First posted: 2022-10-06
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 4500 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 target was 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(Weight for Height Z-score)/BAZ(Body Mass Index for Age Z-score)\<-0,5. Random selection based on age to ensure 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 participants by class into three large groups (300 targets per group)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Evaluating the efficiency of using the nutrient production toward nutrition status (anthropometric index, the prevalence of wasting), digestive disorders, anorexia, and upper respiratory infections in children aged 24 - 71 months.

Detailed description: 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 nutritional product produces a high amount of energy that provides over 468 kcal/100g; 12,5g/100g of protein; 12,5/100 of fat; 59,5g/100g of carbohydrate 1000ng/100g of IgG (immunoglobulin G) Colostrum; 15,3mg/100g of 2'FL HMO (health maintenance organization); 160mg/100g of MCT(Medium chain triglycerides) ; 3,7mg/100g of FOS(Fructo-Oligosaccharide) /Inulin; 810mg/100g of Lysine; 525mg/100g of Calcium; 55,6mg/100g of Magnesium; 5,6mg/100g of Iron; 3mg/100g of Zinc; 35,7µg/100g of Manganese; 8,1µg/100g of Selenium; 1290IU/100g of Vitamin A; 220 IU/100g of Vitamin D3; 33,1µg/100g of Vitamin K1; 510µg/100g of Vitamin B1; 700µg/100g of Vitamin B2; 360µg/100g of Vitamin B6; 1,4µg/100g Vitamin B12; 3120µg/100g of Acid Pantothenic; 62,7µg/100g of Acid Folic. 90 grams of the product which equals 2 packs (210ml x 2 per day) will supply about 33,0% - 43,6% of the required energy for children aged 2-5 years. Other 25 micronutrients and minerals include some essential vitamins such as Calcium 78,8 - 94,5 % RDAs, Iron 91-93% RDAs(recommended daily allowances), Vitamin A 86-103,2% RDAs, Zinc 56-66% RDAs, Vitamin D3 33% RDAs, Selenium 37-43% RDAs, Vitamin K1 43-50% RDAs, Folic Acid 38-56% RDAs. With other elements such as 2'FL HMO (15,3 mg), FOS/inulin (3700 mg), Choline ( 28 mg, Taurin 15,5 mg) ,colostrum IgG 24 1000mg. 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, 45,0 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 nutritional products toward nutrition status ( anthropometric index, the prevalence of wasting), digestive disorders, anorexia, and upper respiratory infections 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: Change of anthropometric indicators and nutrient status (wasting)
timeFrame: Up to 3 months of intervention
measure: Change of digestive disorders, anorexia nervosa, and upper respiratory infections
timeFrame: From date of using the product until the date of first documented improvement, assessed up to 3 months
Secondary outcomes:
measure: Body Mass Index, i.e. changes of Body Mass Index (BMI)
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 of height for age Z-score
timeFrame: over 1 and 3 months
measure: Changes in the percentage of children have anorexia, upper respiratory infections or gastrointestinal diseases
timeFrame: over 1 and 3 months
Other outcomes:
measure: Changes in the percentage of wasted and malnutrition children
timeFrame: over 1 and 3 months
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: