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UndernutritionNCT06708546

Improvement of Nutrition, Digestion, and Respiration in Children in Vietnam Using Oral Nutritional Supplementation

A study testing Dielac Grow Plus 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.

Official record
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Trial summary

Evaluating the effect of using Oral Nutritional Supplementation toward nutrition status, digestive disorders, upper respiratory disorders, and picky eating in children aged 24 - 59 months. Read more about this study

Who is it for?
Ages 24 to 59 months
Conditions the study is for
Undernutrition, Wasting, Malnourished
What is being tested?
Dielac Grow Plus
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
981 participants
Where
1 siteVietnam
Study dates
1 Apr 2023to 1 Feb 2024
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 59 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children between the ages of 24 and 59 months old live in 6 selected communes in Yen Bai province.
  • The family volunteered for the child to participate in the study
  • Z-score height for age <-1 and Z-score weight for height <1
  • Participated in the screening and met the selection criteria

Who cannot join

  • Lactose intolerance
  • Intellectual disability or suffering from acute and chronic infectious diseases.
  • Z-score height for age, Z-score weight for height and Z-score weight for age <-4
  • Planing to move out of the selected trials areas in next 6 months

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 - 59 Months Old.

Evaluating the effect of using Oral Nutritional Supplementation toward nutrition status, digestive disorders, upper respiratory disorders, and picky eating in children aged 24 - 59 months.

Read the detailed description

Evaluating the effect of using Oral Nutritional Supplementation toward improving the nutritional status (anthropometric index, the prevalence of malnutrition) in children aged 24 - 59 months after four months of using the nutritional product.

Evaluating the effect of using Oral Nutritional Supplementation for digestive disorders (diarrhea and constipation), upper respiratory infection and picky eating in children aged 24 - 59 months.

The research involves a randomized controlled clinical trial (RCT), expected from 2023 to 2024 with 1000 children aged 24-59 months. The study will be conducted at schools and homes: 1000 children divided into 2 groups. One group will use the product for 4 months ( with the amount of use: twice per day, 180ml 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 effect of nutritional products toward nutritional status ( anthropometric index, the prevalence of micronutrients), digestive disorders, and picky eating in children aged 24-59 months.

The nutritional product produces a high amount of energy that provides ≥ 380 kcal/360 ml; 2 bottles equal to 180ml x 2 times/day will provide 28-37,3% energy requirement for children aged 2-4 years old. The product includes fat composition which provides 38-44% energy requirement including 1899 mg medium chain triglyceride (MCT), α Linolenic Acid, Linoleic Acid and 26 types of micronutrients and minerals including some essential micronutrients such as Calcium 110- 130% recommended nutrition needs (RNNs), Iron 58-59,3% RNNs, Vitamin A 91-110% RNNs, Zinc 25-28,9% RNNs, Vitamin D3 54% RNNs, Selen 66-77,6% RNNs, Vitamin K1 27-31,7% RNNs, Folic Acid 72-108% RNNs. Including other compositions such as 2'FL HMO (74 mg), Choline (79mg), Taurine (31,2mg)

Being tested
Dielac Grow Plus
Keywords
Picky eating, Children, Digestive condition, Respiratory condition, Wasting, Nutrient status
Medical subject headings
Malnutrition, Cachexia, Food Fussiness

What participants receive

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

  • Dielac Grow PlusDietary supplement

    Dialac Grow Plus is an Oral Nutritional Supplementation made by Vietnam Dairy Products Joint Stock Company - Vinamilk.

    Condition: Liquid

    Color: White

    Date of use: 8 months from the manufactured date.

    Preserve: Store in a clean, dry place, and avoid direct sunlight.

Study groups in NCT06708546
Study groupRoleWhat they receive
Control groupNo intervention(n=490): children eating normally (not using Oral Nutritional Supplementation) during 4 months of intervention. After the end, the product will be used for the following 4 months.
Intervention groupExperimental(n=491): Children eating normally, with 2 boxes of Oral Nutritional Supplementation (180 ml x 2 times/day) as a snack meal. The product will be provided for subjects at school 7 days per week (From Monday to Sunday) and at home or school. Children use Oral Nutritional Supplementation twice per day, the first time at 9 am, and the second at 3 pm.
Receives: Dietary Supplement: Dielac Grow Plus

What is being measured

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

  1. Change of anthropometric indicators

    Children in the intervention group will improve more with the anthropometric indicators (weight, height) than children in the control group.

    This includes weight and height. 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.

    Measured: After 4 months of intervention

  2. Change of digestive conditions

    Children in the intervention group will improve more with digestive conditions includes diarrhea, constipation, respiratory infection and picky eating than children in the control group

    Measured: After 4 months of intervention

  3. Change in micronutrients status

    Children in the intervention group will improve more with the micronutrient status, including the Hb and serum zinc concentrations in blood, than children in the control group.

    Measured: After 4 months of intervention

Secondary outcomes (4)

  1. 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: After 4 months of intervention

  2. 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: After 4 months of intervention

  3. 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: After 4 months of intervention

  4. 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: After 4 months of intervention

Timeline

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

  1. First posted27 Nov 2024
  2. Study start1 Apr 2023
  3. Primary completion1 Jun 2023
  4. Study completion1 Feb 2024

Resources

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 nutritional status of all children aged 24 - 59 months in 6 selected communes in Yen Bai province. Expecting 2000 participants in 6 examined communes. Step 2: After the investigative selection, participants that meet the standard will be invited to the study ( the selected communes can be narrowed if the targets are met). The study will move to the next step when parents sign the consent paper. Step 3: Groups will be divided to investigate activities. Creating a list for all participants that meet the criteria, with Z-score height for age \<-1 and Z-score weight for height\<1. Random selection based on age ensures 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 two large groups (500 targets per group)
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
981 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06708546
Sponsor's protocol ID
DIELACGROW-NIN
Status last verified
Nov 2024
First submitted
5 Jul 2023
Last updated
27 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Dielac Grow Plus 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 4 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 27 Nov 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 (time frame: After 4 months of intervention). The study lists 3 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 NCT06708546.

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 27 Nov 2024.

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