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

NCT06708546 | Completed DMC

• 1 other identifier: DIELACGROW-NIN
• Study Type: interventional
• Target: 981
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Undernutrition; Wasting; Malnourished

Keywords

Picky eating; Children; Digestive condition; Respiratory condition; Wasting; Nutrient status

Outcome Measures

Primary Outcomes (3)

• 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.

  After 4 months of intervention

• 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

  After 4 months of intervention

• 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.

  After 4 months of intervention

Secondary Outcomes (4)

• Change of weight for age Z-score

  After 4 months of intervention

• Change of weight for height Z-score

  After 4 months of intervention

• Change of height for age Z-score

  After 4 months of intervention

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

  After 4 months of intervention

Other Outcomes (1)

• Assessment of Caregivers' Perceptions on the Safety and Effectiveness of the Product in Yen Bai

  After 4 months of intervention

Study Arms (2)

Control group

NO 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 group

EXPERIMENTAL

(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.

Dietary Supplement: Dielac Grow Plus

Interventions

Dielac Grow Plus DIETARY_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.

Intervention group

Eligibility Criteria

• Age: 24 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tu Nguyen Song: lead

Study Sites (1)

Yen Bai Province Obstetrics and Children's Hospital

Yên Bái, 33000, Vietnam

Location

MeSH Terms

Conditions

Malnutrition; Cachexia; Food Fussiness

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; Feeding Behavior; Behavior

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 (490 participants): 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 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.
• 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 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)

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: November 27, 2024
• Study Start: April 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: February 1, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

VN (1)