Gastrointestinal Tolerance of Under-five Children With Severe Acute Malnutrition to ONS Compared to F-75/F-100

NACompletedINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

September 4, 2019

Primary Completion Date

April 15, 2021

Study Completion Date

April 15, 2021

Conditions
Severe Acute Malnutrition
Interventions
OTHER

High Energy Oral Nutrition Supplement

Oral Nutrition Supplement (ONS) or enteral formula is a formula intended to treat individuals who are unable to meet their nutritional requirements through oral diet alone. European Food Safety Authority described ONS as a formula with caloric density \>0.9 kcal/mL. Formula with caloric density of \>1.2 kcal/mL is categorized as high energy ONS. This intervention has caloric density of 1.5 kcal/mL.

OTHER

Standard Energy Oral Nutrition Supplement

Oral Nutrition Supplement (ONS) or enteral formula is a formula intended to treat individuals who are unable to meet their nutritional requirements through oral diet alone. European Food Safety Authority described ONS as a formula with caloric density \>0.9 kcal/mL. This intervention has caloric density of 1 kcal/mL and it is categorized as standard energy ONS.

OTHER

Formula-75/Formula-100

"Formula-75/Formula-100 is a special therapeutic foods to treat children with severe acute malnutrition. WHO designed F75 as a starter formula for stabilization phase with 75 kcal/100 mL, then it is continued with F100 for rehabilitation phase with 100 kcal/100 mL Formula-75 and Formula-100 are made according to recipe from WHO. The ingredients are skimmed milk powder, coconut oil, and sugar. Mineral mix is added, i.e. 2 ml every 100 ml of formula.~The composition of F-75:~Skimmed milk 25 g, coconut oil 100 g, sugar 30 g, mineral mix 20 ml, add water to 1000 ml~The composition of F-100:~Skimmed milk 80 g, coconut oil 50 g, sugar 60 g, mineral mix 20 ml, add water to 1000 ml"

Trial Locations (2)

10430

RSUPN Dr. Cipto Mangunkusumo, Jakarta

12430

RSUP Fatmawati, Jakarta

All Listed Sponsors
collaborator

PT. Nutricia Medical Nutrition

UNKNOWN

lead

Indonesia University

OTHER

NCT04715204 - Gastrointestinal Tolerance of Under-five Children With Severe Acute Malnutrition to ONS Compared to F-75/F-100 | Biotech Hunter | Biotech Hunter