UndernutritionNCT05551637

Evaluating Oral Nutritional Supplements on Children's Nutritional Status and Digestive Health in Vietnam.

A study testing Kazu Gain Gold in people with Undernutrition and Wasting, 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 Oral Nutritional Supplementation toward nutrition status (anthropometric index, the prevalence of wasting), digestive disorders, and anorexic 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: Undernutrition, Wasting, Malnourished
What is being tested?: Kazu Gain Gold
Type of treatment: Pill or oral medicine
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?: Yes, posted in the registrySummary in the doctors' view

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 Nutrition Status, Digestive Disorders, Respiratory Infection and Anorexic in Children Between 24 - 71 Months Old.

Read the 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.

Conditions: Undernutrition, Wasting, Malnourished
Being tested: Kazu Gain Gold
Keywords: Anorexic, Nutrition, Oral Nutritional Supplementation, Children, Digestive Condition, Nutrition Status, Wasting
Medical subject headings: Malnutrition, Cachexia, Anorexia

What participants receive

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

Kazu Gain GoldDietary supplement
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.

Study groups in NCT05551637
Study group	Role	What they receive
control group	No intervention	(n=300): Children eat usual dietary (not using Oral Nutritional Supplementation) for 3 months. After that, they will use the product in 3 months
specific intervention group	Experimental	(n=300): Children eat the usual dietary and use 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 5 days per week (From Monday to Friday) and at home on weekends. Receives: Dietary Supplement: Kazu Gain Gold

What is being measured

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

Improvement of Digestive Disorders and Anorexia Nervosa
Children in intervention group will have more improvement in the digestive disorders and anorexic than children control group
Measured: From date of using the product until the date of first documented improvement, assessed up to 3 months
Change in Weight (kg)
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 centre of the scale. When the balance is stable, read and write the result in kg 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 using the World's Health Organization (WHO) software Anthro and WHO AnthroPlus. Moreover, compare the difference between before intervention and after the intervention. A Z-score of 0 represents the population median. The standard deviations above the median represent a better outcome and vice versa.
Measured: over 1 and 3 months
Change of Weight for Height Z-score
Change of average weight for height Z Score using WHO Anthro and WHO AnthroPlus. Moreover, compare the difference between before intervention and after the intervention. A Z-score of 0 represents the population median. The standard deviations above the median represent a better outcome and vice versa.
Measured: over 1 and 3 months
Change in Height (cm)
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)
Measured: over 1 and 3 months
Change of Height for Age Z-score
Change of average height for age Z Score using WHO Anthro and WHO AnthroPlus. Moreover, compare the difference between before intervention and after the intervention. A Z-score of 0 represents the population median. The standard deviations above the median represent a better outcome and vice versa.
Measured: over 1 and 3 months

Secondary outcomes (2)

Changes in the Rate of Children Have Gastrointestinal Diseases
Changes in the percentage of anorexia, the incidence of gastrointestinal diseases (diarrhea, constipation) after intervention
Measured: over 1 and 3 months
Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting
Changes in the rate of malnutrition and risk of underweight, wasting and stunting after 1, 2 and 3 months of intervention
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 posted22 Sep 2022
Study start1 Aug 2022
Primary completion1 Jul 2023
Study completion1 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for UndernutritionStudies 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 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 blind
Who is masked: Participant, Investigator
Enrolment: 600 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05551637
Sponsor's protocol ID: KAZUGOLD-NIN 176
Status last verified: Jan 2025
First submitted: 20 Sep 2022
Last updated: 14 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
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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All Undernutrition trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study the Efficiency of Oral Nutritional Supplementation on Nutrition Status, Digestive Disorders, Respiratory Infection and Anorexic in Children Between 24 - 71 Months Old.
ClinicalTrials.gov ID: NCT05551637
Acronym / sponsor ID: KAZUGOLD-NIN 176
Conditions: Undernutrition, Wasting, Malnourished
Keywords: Anorexic, Nutrition, Oral Nutritional Supplementation, Children, Digestive Condition, 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 Jul 2023 (actual)
Study completion: 1 Aug 2023 (actual)
First posted: 22 Sep 2022 (actual)
Results: Posted 14 Jan 2025

Clinical summary

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

Detailed description

Evaluating the efficiency of using Oral Nutritional Supplementation for digestive disorders and anorexic in children aged 24 - 71 months.

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 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)

Arm	Type	Receives
control group	No intervention	–(n=300): Children eat usual dietary (not using Oral Nutritional Supplementation) for 3 months. After that, they will use the product in 3 months
specific intervention group	Experimental	Dietary Supplement: Kazu Gain Gold(n=300): Children eat the usual dietary and use 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 5 days per week (From Monday to Friday) and at home on weekends.

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
Kazu Gain GoldKazu 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.	Dietary supplement	specific intervention group

Primary outcome

Improvement of Digestive Disorders and Anorexia Nervosa
Time frame: 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
Change in Weight (kg)
Time frame: 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 centre of the scale. When the balance is stable, read and write the result in kg 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
Time frame: over 1 and 3 months
Change of average weight for age Z Score using the World's Health Organization (WHO) software Anthro and WHO AnthroPlus. Moreover, compare the difference between before intervention and after the intervention. A Z-score of 0 represents the population median. The standard deviations above the median represent a better outcome and vice versa.
Change of Weight for Height Z-score
Time frame: over 1 and 3 months
Change of average weight for height Z Score using WHO Anthro and WHO AnthroPlus. Moreover, compare the difference between before intervention and after the intervention. A Z-score of 0 represents the population median. The standard deviations above the median represent a better outcome and vice versa.
Change in Height (cm)
Time frame: over 1 and 3 months
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 Height for Age Z-score
Time frame: over 1 and 3 months
Change of average height for age Z Score using WHO Anthro and WHO AnthroPlus. Moreover, compare the difference between before intervention and after the intervention. A Z-score of 0 represents the population median. The standard deviations above the median represent a better outcome and vice versa.

2 secondary outcomes

Changes in the Rate of Children Have Gastrointestinal Diseases
Time frame: over 1 and 3 months
Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting
Time frame: over 1 and 3 months

Results and safety

Results posted to the registry on 14 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Group	300	299
Specific Intervention Group	300	293

Primary outcome: Improvement of Digestive Disorders and Anorexia Nervosa

Time frame: From date of using the product until the date of first documented improvement, assessed up to 3 months. Number. Unit: participants

Measure	Control Group n = 299	Specific Intervention Group n = 293
Before intervention (T0)	219	212
After 3 months	175	155

Primary outcome: Change in Weight (kg)

Time frame: over 1 and 3 months. Mean (Standard Deviation). Unit: kilograms

Measure	Control Group n = 299	Specific Intervention Group n = 298
Before intervention (T0)	13.43 (1.99)	13.5 (2.08)
After 1 month (T1)	13.77 (2.06)	14.04 (2.19)
After 2 months (T2)	14.09 (2.03)	14.35 (2.20)
After 3 months (T3)	14.24 (2.03)	14.52 (2.23)
Difference between T1 - T0	0.35 (0.46)	0.54 (0.52)
Difference between T2 - T0	0.66 (0.54)	0.85 (0.59)
Difference between T3 - T0	0.81 (0.53)	1.01 (0.65)

Population analysed: The classified population contains children who had consumed more than 75% of the amount of assigned milk and participated 90% during study time, with enough data on height and weight and interview forms from both assessments to be included in the analysis of the results.

Primary outcome: Change of Weight for Age Z-score

Time frame: over 1 and 3 months. Median (Standard Deviation). Unit: Z-score

Measure	Control Group n = 299	Specific Intervention Group n = 298
Before intervention (T0)	-1.66 (0.70)	-1.62 (0.73)
After 1 month (T1)	-1.58 (0.70)	-1.44 (0.79)
After 2 months (T2)	-1.47 (0.70)	-1.34 (0.77)
After 3 months (T3)	-1.47 (0.71)	-1.33 (0.79)
Difference between T1 - T0	0.07 (0.27)	0.18 (0.31)
Difference between T2 - T0	0.18 (0.31)	0.28 (0.33)
Difference between T3 - T0	0.19 (0.31)	0.29 (0.35)

Primary outcome: Change of Weight for Height Z-score

Time frame: over 1 and 3 months. Median (Standard Deviation). Unit: Z-score

Measure	Control Group n = 299	Specific Intervention Group n = 298
Before intervention (T0)	-1.32 (0.58)	-1.32 (0.60)
After 1 month (T1)	-1.13 (0.61)	-0.98 (0.68)
After 2 months (T2)	-1.03 (0.62)	-0.89 (0.66)
After 3 months (T3)	-0.96 (0.60)	-0.84 (0.66)
Difference between T1 - T0	0.19 (0.40)	0.35 (0.47)
Difference between T2 - T0	0.29 (0.45)	0.43 (0.51)
Difference between T3 - T0	0.36 (0.46)	0.48 (0.53)

Population analysed: Change of average weight for height Z Score and the difference between before intervention and after the intervention

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: At school, the intervention product would passed to teachers (on weekdays) and parents (at weekends). The oral product should be used every day based on the instructions. Observe the participants every day and note down any situation that occurred in the designed notebook. This will continue every day for three months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Group	0 of 299 (0%)	0 of 299 (0%)	0 of 299
Specific Intervention Group	0 of 293 (0%)	0 of 293 (0%)	0 of 293

Limitations and caveats (from the sponsor): Due to research ethics, the intervention and control groups consume the products. Moreover, some children might drink other supplements or products that improve their weight and height at home. However, it does not strongly affect the result of this research

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 Kazu Gain Gold in people with Undernutrition and Wasting, 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 14 Jan 2025. 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?

Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Improvement of Digestive Disorders and Anorexia Nervosa (time frame: From date of using the product until the date of first documented improvement, assessed up to 3 months). The study lists 6 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 NCT05551637.

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 14 Jan 2025.