N/A
N=600
Evaluating Oral Nutritional Supplements on Children's Nutritional Status and Digestive Health in Vietnam.
Undernutrition · Wasting · Malnourished
Bottom Line
View on ClinicalTrials.gov: NCT05551637 ↗Enrolled (actual)
600
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Improvement of Digestive Disorders and Anorexia Nervosa — 219; 212; 175; 155 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Kazu Gain Gold (Dietary_supplement)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Tu Nguyen Song
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Improvement of Digestive Disorders and Anorexia Nervosa |
219; 212; 175; 155 | — |
| PRIMARY Change in Weight (kg) |
13.43; 13.5; 13.77; 14.04; 14.09; 14.35 | — |
| PRIMARY Change of Weight for Age Z-score |
-1.66; -1.62; -1.58; -1.44; -1.47; -1.34 | — |
| PRIMARY Change of Weight for Height Z-score |
-1.32; -1.32; -1.13; -0.98; -1.03; -0.89 | — |
| PRIMARY Change in Height (cm) |
98.34; 98.62; 98.88; 99.14; 99.68; 99.96 | — |
| PRIMARY Change of Height for Age Z-score |
-1.31; -1.24; -1.38; -1.32; -1.30; -1.24 | — |
| SECONDARY Changes in the Rate of Children Have Gastrointestinal Diseases |
3; 11; 5; 3; 4; 1 | — |
| SECONDARY Changes in the Rate of Malnutrition and Risk of Underweight, Stunting and Wasting |
246; 244; 240; 226; 221; 207 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Lactose intolerance
- Children with a history of allergies, congenital diseases
- Intellectual disability or are suffering from acute and chronic infectious diseases
Data sourced from ClinicalTrials.gov (NCT05551637). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.