Evaluating Oral Nutritional Supplements on Children's Nutritional Status and Digestive Health in Vietnam.
NCT ID: NCT05551637
Last Updated: 2025-01-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
600 participants
INTERVENTIONAL
2022-08-01
2023-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Improvement of Nutrition Status, Digestive Conditions, and Upper Respiratory Infections by Using Oral Nutritional Supplementation on Children in Vietnam
NCT05570045
Improvement of Nutrition, Digestion, and Respiration in Children in Vietnam Using Oral Nutritional Supplementation
NCT06708546
Effects of Oral Nutritional Supplementation in Children at Risk of Undernutrition
NCT05239208
Efficacy of a Multiple Micronutrient-Fortified Lipid-Based Nutrient Supplement for Children Under Two in Cambodia
NCT02257762
the Effect of High Caloric Oral Nutritional Supplements on Growth and Development of Malnourished Children
NCT05911893
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
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)
HEALTH_SERVICES_RESEARCH
DOUBLE
Specific Intervention Group (311 participants): Children eat the usual dietary, with 2 glasses of Oral Nutritional Supplementation as the side meal. The product provides GOS, Calcium, Probiotics, HMO, DHA, and Taurine within 3 months of use.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
No interventions assigned to this group
specific intervention group
(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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Children with a history of allergies, congenital diseases
* Intellectual disability or are suffering from acute and chronic infectious diseases
24 Months
71 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tu Nguyen Song
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Tu Nguyen Song
Head of Division Planning
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Division of Planning National Institute of Nutrition
Role: PRINCIPAL_INVESTIGATOR
National Institute of Nutrition, Vietnam
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Yen Bai Province Obstetrics and Children's Hospital
Yên Bái, , Vietnam
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KAZUGOLD-NIN 176
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.