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

Sponsor

Tu Nguyen Song (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05551637

Collaborator

(none)

600

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Undernutrition Wasting Malnourished	Dietary Supplement: Kazu Gain Gold	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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)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)

Masking:

Double (Participant, Investigator)

Masking Description:

Control Group (300 participants): Children eat usual dietary(not using Oral Nutritional Supplementation) for 3 months. After that, they will use the product for 3 months. Specific Intervention Group (300 participants): Children eat usual dietary, with 2 glasses of Oral Nutritional Supplementation as the side meals. The product provides GOS, Calcium, Probiotics, HMO, DHA, and Taurine within 3 months of use.

Primary Purpose:

Health Services Research

Official Title:

Study the Efficiency of Oral Nutritional Supplementation on Anthropometric Indicators (Weight, Height), Nutrition Status, Digestive Disorders (Diarrhea, Constipation), and Anorexic in Children Between 24 - 71 Months Old.

Actual Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: control group (n=300): Children eat usual dietary (not using Oral Nutritional Supplementation) for 3 months. After that, they will use the product in 3 months
Experimental: specific intervention group (n=300): Children eat usual dietary and using 2 glasses (49,2 gr powdered milk x 180 ml boil water/time x 2 times/day) of the Oral Nutritional Supplementation as the side meals. The product provides GOS, Calcium, Probiotics, HMO, DHA, and Taurine within 3 months of use. The product will be provided for subjects at school in 5 days per week (From Monday to Friday) and at home on weekend.	Dietary Supplement: Kazu Gain Gold Kazu Gain Gold is an Oral Nutritional Supplementation made by AIWAIDO Food 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. User Manual: Mix 6 spoons of Kazu Gain Gold (equal to 49,2 grams) with 180 ml of warm water (The energy density reaches 1kal/ml). Consume 2 glasses per day or follow the directions from the medical staff. 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.

Arm

Intervention/Treatment

No Intervention: control group

(n=300): Children eat usual dietary (not using Oral Nutritional Supplementation) for 3 months. After that, they will use the product in 3 months

Experimental: specific intervention group

(n=300): Children eat usual dietary and using 2 glasses (49,2 gr powdered milk x 180 ml boil water/time x 2 times/day) of the Oral Nutritional Supplementation as the side meals. The product provides GOS, Calcium, Probiotics, HMO, DHA, and Taurine within 3 months of use. The product will be provided for subjects at school in 5 days per week (From Monday to Friday) and at home on weekend.

Dietary Supplement: Kazu Gain Gold

Kazu Gain Gold is an Oral Nutritional Supplementation made by AIWAIDO Food 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. User Manual: Mix 6 spoons of Kazu Gain Gold (equal to 49,2 grams) with 180 ml of warm water (The energy density reaches 1kal/ml). Consume 2 glasses per day or follow the directions from the medical staff. 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.

Outcome Measures

Primary Outcome Measures

Improvement of anthropometric indicators and nutrient status (wasting) [Up to 3 months of intervention]
Children in the intervention group will have more improvement with the anthropometric indicators (weight, height) than children in control group
Improvement of digestive disorders and anorexia nervosa [From date of using the product until the date of first documented improvement, assessed up to 3 months]
Children in intervention group will have more improvement in the digestive disorders and anorexic than children control group

Secondary Outcome Measures

Body Mass Index, i.e. changes of Body Mass Index (BMI) [over 1 and 3 months]
Weight is measured in kg with one decimal value by the Body composition analyzer TANITA scale. The scale is checked and adjusted before use. Children wear light clothing, remove shoes and sandals, and sit or lie balanced, at the center of the scale. As soon as the balance is stable, read and write the result in kg and an odd number after the comma. A wooden stadiometer measures height by precisely 0.1cm. Children stand up straight, their eyes look straight, and the top of their head touches the wooden shelf fixed at a 0 cm position. The child's whole body ensures that 9 points touch the surface of the ruler: occipital, shoulder blade, buttocks, calf, and heel. The result is recorded in cm and an odd number after the comma. All data will be measured at the time T0 (at baseline) and T3 (after 3 months)
Change of weight for age Z-score [over 1 and 3 months]
Change of average weight for age Z Score and the difference between before intervention and after the intervention
Change of weight for height Z-score [over 1 and 3 months]
Change of average weight for height Z Score and the difference between before intervention and after the intervention
Change of height for age Z-score [over 1 and 3 months]
Change of average height for age Z Score and the difference between before intervention and after the intervention
Changes in the rate of children have anorexia or gastrointestinal diseases [over 1 and 3 months]
Changes in the percentage of anorexia, the incidence of gastrointestinal diseases (diarrhea, constipation), and anorexia above after intervention

Other Outcome Measures

Changes in the risk of wasting and malnutrition [over 1 and 3 months]
Changes in the risk of wasting and malnutrition after 1, 2 and 3 months of intervention
The change in the rate of wasting and malnutrition [over 1 and 3 months]
The change in the rate of wasting and malnutrition after 1, 2, and 3 months of intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

24 Months to 71 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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