Improvement of Nutrition Status, Digestive Conditions, and Upper Respiratory Infections by Using Oral Nutritional Supplementation on Children in Vietnam

NCT05570045 | Completed DMC

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

Brief Summary

Evaluating the efficiency of using the nutrient production toward nutrition status (anthropometric index, the prevalence of wasting), digestive disorders, anorexia, and upper respiratory infections in children aged 24 - 71 months.

Conditions

Wasting; Undernutrition; Malnourished; Malnutrition

Keywords

children; oral nutrition supplementation; anorexic; anorexia nervosa; digestive disorders; upper respiratory infections; nutrition status; wasting

Outcome Measures

Primary Outcomes (2)

• Change of anthropometric indicators and nutrient status (wasting)

  Children in the intervention group will improve more with the anthropometric indicators (weight, height) than children in the control group. 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. The nutrient status will be measure base on the changes in weight and height, also on

  Up to 3 months of intervention

• Change of digestive disorders, anorexia nervosa, and upper respiratory infections

  Children in the intervention group improved more in digestive disorders, anorexia, and upper respiratory infections than in the control group. The changes in digestive disorders would illustrate in children defecating activities

  From date of using the product until the date of first documented improvement, assessed up to 3 months

Secondary Outcomes (5)

• Body Mass Index, i.e. changes of Body Mass Index (BMI)

  over 1 and 3 months

• Change of weight for age Z-score

  over 1 and 3 months

• Change of weight for height Z-score

  over 1 and 3 months

• Change of height for age Z-score

  over 1 and 3 months

• Changes in the percentage of children have anorexia, upper respiratory infections or gastrointestinal diseases

  over 1 and 3 months

Other Outcomes (1)

• Changes in the percentage of wasted and malnutrition children

  over 1 and 3 months

Study Arms (2)

Usual Diet

NO INTERVENTION

(n=300): Children eat usual dietary (not using nutrient products) for 3 months. After that, they will use the products

Colos Gain Dietary Supplement

EXPERIMENTAL

(n=300): Children eat usual dietary, but with 2 glasses of the nutrient product as the side meals. The product provides GOS(Galactooligosaccharides), Calcium, Probiotics, HMO, DHA, and Taurine within 3 months of use.

Dietary Supplement: Colos Gain

Interventions

Colos Gain DIETARY_SUPPLEMENT

Dietary Supplement: Colos Gain Colos Gain is a nutrient product made by VITADAIRY Dairy 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. Direction: Mix 5 spoons of Colos Gain (equal to 45 grams) with 180 ml of warm water (50˚C) which provides 210kcal (The energy density reaches 1kal/ml). Consume 2-3 glasses per day or follow the directions from the medical supervisors. 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.

Colos Gain Dietary Supplement

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

Cachexia; Malnutrition; Anorexia; Anorexia Nervosa; Digestive System Diseases; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Mental Disorders; Infections; Respiratory Tract Diseases

Study Officials

• Division of Planning National Institute of Nutrition

  National Institute of Nutrition, Vietnam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Control Group (300 participants): Children eat usual dietary(not using nutrient products) for 3 months. After that, they will use the product. Intervention Group (300 participants): Children eat usual dietary, but with 2 glasses of the nutrient product as the side meals. The product provides L-lysin, IgG 24h Colostrum, Calcium, Probiotics, HMO, DHA(Docosa Hexaenoic Acid), 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 4500 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 target was 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(Weight for Height Z-score)/BAZ(Body Mass Index for Age Z-score)\<-0,5. Random selection based on age to ensure 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 participants by class into three large groups (300 targets per group)

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: October 6, 2022
• Study Start: August 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: August 1, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)