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

NCT05551637 | Completed Results DMC

• 1 other identifier: KAZUGOLD-NIN 176
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Undernutrition; Wasting; Malnourished

Keywords

Anorexic; Nutrition; Oral Nutritional Supplementation; Children; Digestive Condition; Nutrition Status; Wasting

Outcome Measures

Primary Outcomes (6)

• 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

  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)

  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.

  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.

  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)

  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.

  over 1 and 3 months

Secondary Outcomes (2)

• Changes in the Rate of Children Have Gastrointestinal Diseases

  over 1 and 3 months

• Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting

  over 1 and 3 months

Study Arms (2)

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.

Dietary Supplement: Kazu Gain Gold

Interventions

Kazu Gain Gold DIETARY_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.

specific intervention group

Eligibility Criteria

• Age: 24 Months - 71 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Tu Nguyen Song: lead

Study Sites (1)

Yen Bai Province Obstetrics and Children's Hospital

Yên Bái, 33000, Vietnam

Location

Related Links

• 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.

MeSH Terms

Conditions

Malnutrition; Cachexia; Anorexia

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Signs and Symptoms, Digestive

Limitations and Caveats

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

Results Point of Contact

• Title: Dr. Nguyen Song Tu
• Organization: National Institute of Nutrient

nguyensongtu@gmail.com

0912322602

Study Officials

• Division of Planning National Institute of Nutrition

  National Institute of Nutrition, Vietnam

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Control Group (311 participants): Children eat their usual dietary(not using Oral Nutritional Supplementation) for 3 months. After that, they will use the product for 3 months. 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Division Planning

Model Details: 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)

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 22, 2022
• Study Start: August 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: January 14, 2025
• Results First Posted: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)