Improvement of Nutrition, Digestion, and Respiration in Children in Vietnam Using Oral Nutritional Supplementation
NCT ID: NCT06708546
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
981 participants
INTERVENTIONAL
2023-04-01
2024-02-01
Brief Summary
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Detailed Description
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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)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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)
HEALTH_SERVICES_RESEARCH
DOUBLE
Intervention Group (491 participants): children eating normally, with 2 boxes of Oral Nutritional Supplementation (180ml each) as a snack meal. The product provides 9,5% milk powder, milk fat and 26 micronutrients and provides FOS, HMO, DHA, and Taurine within 4 months of use.
Study Groups
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Control group
(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.
No interventions assigned to this group
Intervention group
(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.
Dielac Grow Plus
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.
Interventions
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Dielac Grow Plus
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
24 Months
59 Months
ALL
No
Sponsors
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Tu Nguyen Song
OTHER_GOV
Responsible Party
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Tu Nguyen Song
Head of Division Planning
Principal Investigators
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Division of Planning National Institute of Nutrition
Role: PRINCIPAL_INVESTIGATOR
National Institute of Nutrition, Vietnam
Locations
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Yen Bai Province Obstetrics and Children's Hospital
Yên Bái, , Vietnam
Countries
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Other Identifiers
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DIELACGROW-NIN
Identifier Type: -
Identifier Source: org_study_id