Gastrointestinal Tolerance of Under-five Children With Severe Acute Malnutrition to ONS Compared to F-75/F-100
NCT ID: NCT04715204
Last Updated: 2021-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
108 participants
INTERVENTIONAL
2019-09-04
2021-04-15
Brief Summary
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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.
Detailed Description
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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:
* Calorie requirement is calculated by multiplying ideal weight with daily energy requirement (recommended daily allowance, RDA).
* Ideal weight is the median weight for actual height based on WHO growth chart (weight for height/length).
* Height age is the median age corresponding to actual height of patient, based on WHO growth chart (height/length for age)
* The value of RDA is based on height age, which is 110 kcal/day for height age 0-12 months and 100 kcal/kg/day
1. On the first day: patient is given 50-75% of RDA (recommended daily allowance), the daily volume of formula (F75/standard energy ONS/high energy ONS) will be divided into 8 feeding sessions (every 3 hours). Complete blood count, electrolyte, and amino acid profile will be tested prior to administering formula.
2. On the second day: patient is given 75-90% of RDA as F75/standard energy ONS/high energy ONS.
3. On the third day: patient is given 100% of RDA as F100/standard energy ONS/high energy ONS. Serum electrolyte will be tested before administering formula.
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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Formula-75/Formula-100
This arm is the control. Formula-75/Formula-100 are the standard formula recommended by WHO to treat severely malnourished children.
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
High Energy Oral Nutrition Supplement
High energy oral nutrition supplement (ONS) has energy density of 1.5 kcal/ml, with protein-energy ratio of 8.9% and complete micronutrients. It is also named as enteral formula and can be used as a sole source of nutrition. It comes as a ready-to-drink bottled package of 200 mL each. The nutrition fact fulfills the requirement of BPOM (Indonesian Food and Drug Authority) for Special Medical Purpose. The ready-to-drink formula is a safe option to treat severely malnourished patient in terms of hygiene assurance of formula. In Indonesia, many severely malnourished children come from areas with poor access to clean water and proper sanitation. The high energy ONS is beneficial for children who cannot tolerate large volume of feeding.
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.
Standard Energy Oral Nutrition Supplement
Standard energy oral nutrition supplement (ONS) has energy density of 1 kcal/ml, with protein-energy ratio of 9.6% and complete micronutrients. It is also named as enteral formula and can be used as a sole source of nutrition. It comes as a ready-to-drink bottled package of 200 mL each. The nutrition fact fulfills the requirement of BPOM (Indonesian Food and Drug Authority) for Special Medical Purpose. The ready-to-drink formula is a safe option to treat severely malnourished patient in terms of hygiene assurance of formula. In Indonesia, many severely malnourished children come from areas with poor access to clean water and proper sanitation.
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.
Interventions
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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.
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.
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Weight for length/height z score \< -3 (WHO 2006)
* Not on nutritional treatment of severe acute malnutrition for the last 1 month
Exclusion Criteria
* Having diarrhea
* Diagnosed with malignancy or suspected malignancy
12 Months
60 Months
ALL
No
Sponsors
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PT. Nutricia Medical Nutrition
UNKNOWN
Indonesia University
OTHER
Responsible Party
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Klara Yuliarti
Principal Investigator
Principal Investigators
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Klara Yuliarti, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Pediatric, Faculty of Medicine, University of Indonesia/ Cipto Mangunkusumo Hospital
Locations
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RSUPN Dr. Cipto Mangunkusumo
Jakarta, DKI Jakarta, Indonesia
RSUP Fatmawati
Jakarta, DKI Jakarta, Indonesia
Countries
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Other Identifiers
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19-04-0406
Identifier Type: -
Identifier Source: org_study_id