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

Primary Purpose

Wasting, Undernutrition, Malnourished

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Colos Gain
Sponsored by
Tu Nguyen Song
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Wasting focused on measuring children, oral nutrition supplementation, anorexic, anorexia nervosa, digestive disorders, upper respiratory infections, nutrition status, wasting

Eligibility Criteria

24 Months - 71 Months (Child)All SexesDoes not accept 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

Sites / Locations

  • Yen Bai Province Obstetrics and Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Diet

Colos Gain Dietary Supplement

Arm Description

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

(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.

Outcomes

Primary Outcome Measures

Change of anthropometric indicators and nutrient status (wasting)
Children in the intervention group will improve more with the anthropometric indicators (weight, height) than children in the control group. Weight is measured in kg with one decimal value by the Body composition analyzer called the TANITA scale. Children wear light clothes while measuring. A wooden stadiometer measures height by precisely 0.1cm. The nutrient status will be measure base on the changes in weight and height, also on
Change of digestive disorders, anorexia nervosa, and upper respiratory infections
Children in the intervention group improved more in digestive disorders, anorexia, and upper respiratory infections than in the control group. The changes in digestive disorders would illustrate in children defecating activities

Secondary Outcome Measures

Body Mass Index, i.e. changes of Body Mass Index (BMI)
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 centimeters 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
Change of average weight for age Z Score and the difference between before intervention and after the intervention. 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. Age of the child is calculated by subtracting the date of birth from the census date and classified according to WHO (World Health Organization) , 2006
Change of weight for height Z-score
Change of average weight for height Z Score and the difference between before intervention and after the intervention. 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 centimeter and an odd number after the comma.
Change of height for age Z-score
Change of average height for age Z Score and the difference between before intervention and after the intervention. 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 centimeters and an odd number after the comma. Age of the child is calculated by subtracting the date of birth from the census date, and classified according to WHO, 2006
Changes in the percentage of children have anorexia, upper respiratory infections or gastrointestinal diseases
Changes in the percentage of anorexia, the percentage of gastrointestinal diseases (diarrhea, constipation), and anorexia above after intervention. The changes in digestive disorders would demonstrate in children defecating activities

Full Information

First Posted
September 26, 2022
Last Updated
October 3, 2022
Sponsor
Tu Nguyen Song
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1. Study Identification

Unique Protocol Identification Number
NCT05570045
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tu Nguyen Song

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wasting, Undernutrition, Malnourished, Malnutrition
Keywords
children, oral nutrition supplementation, anorexic, anorexia nervosa, digestive disorders, upper respiratory infections, nutrition status, wasting

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Diet
Arm Type
No Intervention
Arm Description
(n=300): Children eat usual dietary (not using nutrient products) for 3 months. After that, they will use the products
Arm Title
Colos Gain Dietary Supplement
Arm Type
Experimental
Arm Description
(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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Colos Gain
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of anthropometric indicators and nutrient status (wasting)
Description
Children in the intervention group will improve more with the anthropometric indicators (weight, height) than children in the control group. Weight is measured in kg with one decimal value by the Body composition analyzer called the TANITA scale. Children wear light clothes while measuring. A wooden stadiometer measures height by precisely 0.1cm. The nutrient status will be measure base on the changes in weight and height, also on
Time Frame
Up to 3 months of intervention
Title
Change of digestive disorders, anorexia nervosa, and upper respiratory infections
Description
Children in the intervention group improved more in digestive disorders, anorexia, and upper respiratory infections than in the control group. The changes in digestive disorders would illustrate in children defecating activities
Time Frame
From date of using the product until the date of first documented improvement, assessed up to 3 months
Secondary Outcome Measure Information:
Title
Body Mass Index, i.e. changes of Body Mass Index (BMI)
Description
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 centimeters and an odd number after the comma. All data will be measured at the time T0 (at baseline) and T3 (after 3 months)
Time Frame
over 1 and 3 months
Title
Change of weight for age Z-score
Description
Change of average weight for age Z Score and the difference between before intervention and after the intervention. 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. Age of the child is calculated by subtracting the date of birth from the census date and classified according to WHO (World Health Organization) , 2006
Time Frame
over 1 and 3 months
Title
Change of weight for height Z-score
Description
Change of average weight for height Z Score and the difference between before intervention and after the intervention. 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 centimeter and an odd number after the comma.
Time Frame
over 1 and 3 months
Title
Change of height for age Z-score
Description
Change of average height for age Z Score and the difference between before intervention and after the intervention. 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 centimeters and an odd number after the comma. Age of the child is calculated by subtracting the date of birth from the census date, and classified according to WHO, 2006
Time Frame
over 1 and 3 months
Title
Changes in the percentage of children have anorexia, upper respiratory infections or gastrointestinal diseases
Description
Changes in the percentage of anorexia, the percentage of gastrointestinal diseases (diarrhea, constipation), and anorexia above after intervention. The changes in digestive disorders would demonstrate in children defecating activities
Time Frame
over 1 and 3 months
Other Pre-specified Outcome Measures:
Title
Changes in the percentage of wasted and malnutrition children
Description
Changes in the risk of wasting and malnutrition after 1, 2, and 3 months of intervention. Data were entered using Epidata 3.1 software. Data analysis using the software called SPSS 18.0. Anthropometric data were processed using Anthro software from WHO, 2006. Statistics were used to analyze the data of the squared test (χ2-test) and Fisher's exact test to compare the difference between the samples. ratio; Mc Nemar -test compares the difference in the percentage of malnutrition of each study group before and after the intervention. The rate of children got wasting and malnutrition will decrease as the body index increase over time. The measurement would be done by a TANITA scale and a wooden stadiometer.
Time Frame
over 1 and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
71 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Division of Planning National Institute of Nutrition
Organizational Affiliation
National Institute of Nutrition, Vietnam
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yen Bai Province Obstetrics and Children's Hospital
City
Yen Bai
ZIP/Postal Code
33000
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://viendinhduong.vn/en/home.html
Description
Click here for more information about the organization in which this study is conducted. The Division of Planning is responsible to plan and implement the project.

Learn more about this trial

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

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