NCT Number: NCT04715204
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.
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Notify Me12 month–60 month
All sexes
Interventional
Not applicable
RSUP Fatmawati, Jakarta, DKI Jakarta, Indonesia
The study compares 3 groups of nutrition intervention for severe acute malnourished children aged 6-59 months in terms of gastrointestinal tolerance (primary outcome) and weight gain, electrolyte profile, and amino acid profile (secondary outcomes).
The gastrointestinal tolerance is examined by Bristol stool chart and vomit daily record during 14 days of intervention. Diarrhea is defined according to ESPGHAN, i.e. a decrease in the consistency of stools score (loose or liquid) and an increase in the frequency of evacuations (typically 3 or more in 24 hours). The duration of diarrhea, frequency of diarrhea, and consistency of each stool are recorded.
Vomit will be counted as mean frequency of vomit per day during 14 days intervention. Volume of vomit is recorded. Only vomit due to milk intolerance is counted. Vomit due to irrelevant reasons, such as coughing and crying, will be excluded.
To ensure accurate formula intake, nasogastric tube is placed and patient is admitted for observation for a few days, depending on clinical conditions. Patient is discharged to undergo home enteral nutrition after parent is trained to administer formula and to clean all feeding devices properly. Parents of group F-75/F-100 is trained to make F-75/F-100 at home with hygienic procedure.
The volume of milk intake is recorded daily. Patient is advised not to eat food/drink milk other than the intervention formula.
Protocol for formula advancement is as follows:
Should there be any electrolyte imbalance, the electrolyte level will be corrected according to the clinical guideline.
Weight and height will be measured on the first day and day 14. Head circumference will be measured on the first day.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: High Energy ONS
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 names: Standard Energy ONS
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
Other names: F75/F100
Time frame: 14 days
Frequency of bowel movement per day and description of stool consistency (Bristol stool chart)
Time frame: 14 days
Frequency of vomit per day and volume of vomit
Time frame: 14 days
Weight is measured on day 1 (before intervention) and day 14 (after intervention) in kilogram with 3 decimals. The weight gain is defined as weight on day 14 minus weight on day 1 and will be presented as gram/kg/day.
Weight on day 1 and day 14 will also be plotted on WHO Growth Chart weight-for-height z-score and the change of weight-for-height z-score will also be measured.
Time frame: 14 days
Height is measured on day 1 (before intervention) and day 14 (after intervention) in kg with 1 decimals. The height gain is defined as height on day 14 minus height on day 1 and will be presented as centimeter.
Height on day 1 and day 14 will also be plotted on WHO Growth Chart height-for-age z-score and the change of height-for-age z-score will also be measured.
Time frame: Day 1 and day 3
Prevalence of hypokalemia on day 1 (starting of stabilization phase) and on day 3 (starting of rehabilitation phase). Hypokalemia is defined as serum potassium lower than 3.5 mEq/L.
Time frame: Day 1 and day 3
Prevalence of hypophosphatemia on day 1 (starting of stabilization phase) and on day 3 (starting of rehabilitation phase). Hypophosphatemia is defined as serum phophorus inorganic lower than 4 mg/dL (1.29 mmol/L).
Time frame: Day 1 and day 3
Prevalence of hypomagnesemia on day 1 (starting of stabilization phase) and on day 3 (starting of rehabilitation phase). Hypomagnesemia is defined as serum magnesium lower than 1.7 mg/dL (0.7 mmol/L).
Time frame: Day 1 and day 14
Changes of plasma amino acid concentration between day 1 (beginning of study, stabilization phase) and day 14 (end of the study). Plasma amino acid analysis method is derivatization with butanolic chloride/LC-MS/MS and the measurement result will be presented as µmol/L.
Indonesia University
Other
Gastrointestinal Tolerance of Under-five Children With Severe Acute Malnutrition to Ready-to-Drink High Energy and Standard Energy Oral Nutrition Supplement Compared to Formula-75/Formula-100
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