Improvement of Nutrition Status, Digestive Conditions, and Upper Respiratory Infections by Using Oral Nutritional Supplementation on Children in Vietnam

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-08-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Wasting Undernutrition Malnourished Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Control Group (300 participants): Children eat usual dietary(not using nutrient products) for 3 months. After that, they will use the product.

Intervention Group (300 participants): Children eat usual dietary, but with 2 glasses of the nutrient product as the side meals. The product provides L-lysin, IgG 24h Colostrum, Calcium, Probiotics, HMO, DHA(Docosa Hexaenoic Acid), and Taurine within 3 months of use.

Study Groups

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Usual Diet

(n=300): Children eat usual dietary (not using nutrient products) for 3 months. After that, they will use the products

Group Type NO_INTERVENTION

No interventions assigned to this group

Colos Gain Dietary Supplement

(n=300): Children eat usual dietary, but with 2 glasses of the nutrient product as the side meals. The product provides GOS(Galactooligosaccharides), Calcium, Probiotics, HMO, DHA, and Taurine within 3 months of use.

Group Type EXPERIMENTAL

Colos Gain

Intervention Type DIETARY_SUPPLEMENT

Dietary Supplement: Colos Gain Colos Gain is a nutrient product made by VITADAIRY Dairy Joint Stock Company.

Condition: Powder

Color: White to light yellow

Scent: The fresh scent of milk, gracious sugary smell.

Date of use: 24 months from the manufactured date.

Direction: Mix 5 spoons of Colos Gain (equal to 45 grams) with 180 ml of warm water (50˚C) which provides 210kcal (The energy density reaches 1kal/ml). Consume 2-3 glasses per day or follow the directions from the medical supervisors.

The product should consume less than 1 hour. Do not let the child eat the leftovers of the previous meal.

Preserve: Store in a clean, dry place, and keep away from direct sunlight. Opened can or package must be closed and used up within 3 weeks.

Interventions

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Colos Gain

Dietary Supplement: Colos Gain Colos Gain is a nutrient product made by VITADAIRY Dairy Joint Stock Company.

Condition: Powder

Color: White to light yellow

Scent: The fresh scent of milk, gracious sugary smell.

Date of use: 24 months from the manufactured date.

Direction: Mix 5 spoons of Colos Gain (equal to 45 grams) with 180 ml of warm water (50˚C) which provides 210kcal (The energy density reaches 1kal/ml). Consume 2-3 glasses per day or follow the directions from the medical supervisors.

The product should consume less than 1 hour. Do not let the child eat the leftovers of the previous meal.

Preserve: Store in a clean, dry place, and keep away from direct sunlight. Opened can or package must be closed and used up within 3 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

24 Months

Maximum Eligible Age

71 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No