Last reviewed · How we verify
Gastrointestinal Tolerance of Under-five Children With Severe Acute Malnutrition to ONS Compared to F-75/F-100
The primary outcome of the study is to identify gastrointestinal tolerance of under-five children with severe acute malnutrition to ready-to-drink high energy (1.5 kcal/ml) and standard energy (1 kcal/ml) oral nutrition supplement (ONS) compared to Formula-75/Formula-100. The secondary outcomes of the study are weight gain, electrolyte profile and plasma amino acid profile at the beginning and the end of stabilization phase. In this randomized, controlled trial, 108 patients with severe acute malnutrition will be enrolled. Patients are randomly assigned to 3 groups (Formula-75/Formula-100, high energy ONS, and standard energy ONS) to undergo a two-week treatment. In order to ensure an adequate intake, nasogastric-tube will be placed for home enteral nutrition for at least throughout the two-week study period. Parent or caregiver will be asked to record daily intake, vomit, and defecation score using Bristol stool chart.
Details
| Lead sponsor | Indonesia University |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 108 |
| Start date | Wed Sep 04 2019 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Thu Apr 15 2021 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Severe Acute Malnutrition
Interventions
- High Energy Oral Nutrition Supplement
- Standard Energy Oral Nutrition Supplement
- Formula-75/Formula-100
Countries
Indonesia