WastingNCT05570045

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

A study testing Colos Gain in people with Wasting and Undernutrition, run by Tu Nguyen Song at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 24 to 71 months
Conditions the study is for: Wasting, Undernutrition, Malnourished
What is being tested?: Colos Gain
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 600 participants
Where: 1 siteVietnam
Study dates: 1 Aug 2022to 1 Aug 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 24 to 71 months
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

Lactose intolerance
Children with a history of allergies, congenital diseases
Intellectual disability or are suffering from acute and chronic infectious diseases

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

Yen Bai Province Obstetrics and Children's Hospital
Yên Bái, 33000

Other trials in Vietnam

About this study

Official title: Study the Efficiency of Oral Nutritional Supplementation on Anthropometric Indicators, Nutrition Status, Digestive Disorders, Anorexic and Upper Respiratory Infections in Children

Read the 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.

Conditions: Wasting, Undernutrition, Malnourished, Malnutrition
Being tested: Colos Gain
Keywords: children, oral nutrition supplementation, anorexic, anorexia nervosa, digestive disorders, upper respiratory infections, nutrition status, wasting
Medical subject headings: Cachexia, Malnutrition, Anorexia, Anorexia Nervosa, Digestive System Diseases, Respiratory Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Colos GainDietary 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.

Study groups in NCT05570045
Study group	Role	What they receive
Usual Diet	No intervention	(n=300): Children eat usual dietary (not using nutrient products) for 3 months. After that, they will use the products
Colos Gain Dietary Supplement	Experimental	(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. Receives: Dietary Supplement: Colos Gain

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Up to 3 months of intervention
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
Measured: From date of using the product until the date of first documented improvement, assessed up to 3 months

Secondary outcomes (5)

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)
Measured: over 1 and 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
Measured: over 1 and 3 months
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.
Measured: over 1 and 3 months
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
Measured: over 1 and 3 months
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
Measured: over 1 and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20221 Aug 2023

First posted6 Oct 2022
Study start1 Aug 2022
Primary completion1 Jan 2023
Study completion1 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for WastingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 600 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05570045
Sponsor's protocol ID: COLOS-NIN
Status last verified: Feb 2024
First submitted: 26 Sep 2022
Last updated: 20 Feb 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study the Efficiency of Oral Nutritional Supplementation on Anthropometric Indicators, Nutrition Status, Digestive Disorders, Anorexic and Upper Respiratory Infections in Children
ClinicalTrials.gov ID: NCT05570045
Acronym / sponsor ID: COLOS-NIN
Conditions: Wasting, Undernutrition, Malnourished, Malnutrition
Keywords: children, oral nutrition supplementation, anorexic, anorexia nervosa, digestive disorders, upper respiratory infections, nutrition status, wasting
Study type: Interventional
Recruitment status: Completed
Enrolment: 600 participants (actual)
Lead sponsor: Tu Nguyen SongOther government
Study start: 1 Aug 2022 (actual)
Primary completion: 1 Jan 2023 (actual)
Study completion: 1 Aug 2023 (actual)
First posted: 6 Oct 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
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)

Arm	Type	Receives
Usual Diet	No intervention	–(n=300): Children eat usual dietary (not using nutrient products) for 3 months. After that, they will use the products
Colos Gain Dietary Supplement	Experimental	Dietary Supplement: Colos Gain(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.

Who may qualify

Ages: 24 to 71 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

Lactose intolerance
Children with a history of allergies, congenital diseases
Intellectual disability or are suffering from acute and chronic infectious diseases

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Colos GainDietary 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.	Dietary supplement	Colos Gain Dietary Supplement

Primary outcome

Change of anthropometric indicators and nutrient status (wasting)
Time frame: Up to 3 months of intervention
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
Time frame: From date of using the product until the date of first documented improvement, assessed up to 3 months
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

5 secondary outcomes

Body Mass Index, i.e. changes of Body Mass Index (BMI)
Time frame: over 1 and 3 months
Change of weight for age Z-score
Time frame: over 1 and 3 months
Change of weight for height Z-score
Time frame: over 1 and 3 months
Change of height for age Z-score
Time frame: over 1 and 3 months
Changes in the percentage of children have anorexia, upper respiratory infections or gastrointestinal diseases
Time frame: over 1 and 3 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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.Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Division of Planning National Institute of Nutrition principal investigator

National Institute of Nutrition, Vietnam

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Colos Gain in people with Wasting and Undernutrition, run by Tu Nguyen Song at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of anthropometric indicators and nutrient status (wasting) (time frame: Up to 3 months of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05570045.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.