Severe Acute MalnutritionNCT04715204
Gastrointestinal Tolerance of Under-five Children With Severe Acute Malnutrition to ONS Compared to F-75/F-100
A study testing High Energy Oral Nutrition Supplement, Standard Energy Oral Nutrition Supplement and Formula-75/Formula-100 in people with Severe Acute Malnutrition, run by Universitas Indonesia at 2 sites in Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 60 months
- Conditions the study is for
- Severe Acute Malnutrition
- What is being tested?
- High Energy Oral Nutrition Supplement, Standard Energy Oral Nutrition Supplement and Formula-75/Formula-100
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesIndonesia
- Study dates
- 4 Sep 2019to 15 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 12-60 months
- Weight for length/height z score < -3 (WHO 2006)
- Not on nutritional treatment of severe acute malnutrition for the last 1 month
Who cannot join
- Not willing to take part in this study
- Having diarrhea
- Diagnosed with malignancy or suspected malignancy
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
RSUPN Dr. Cipto Mangunkusumo
Jakarta, DKI Jakarta, 10430
RSUP Fatmawati
Jakarta, DKI Jakarta, 12430
About this study
Official title: 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
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.
Read the detailed description
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:
- 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
- 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.
- On the second day: patient is given 75-90% of RDA as F75/standard energy ONS/high energy ONS.
- 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
- Severe Acute Malnutrition
- Being tested
- High Energy Oral Nutrition Supplement, Standard Energy Oral Nutrition Supplement, Formula-75/Formula-100
- Keywords
- severe acute malnutrition, oral nutrition supplement, Formula-75/Formula-100, Under-five children
- Medical subject headings
- Severe Acute Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Energy Oral Nutrition SupplementOther
Also called 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. 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 SupplementOther
Also called Standard 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.
Formula-75/Formula-100Other
Also called F75/F100
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
| Study group | Role | What they receive |
|---|---|---|
| Formula-75/Formula-100 | Active comparator | This arm is the control. Formula-75/Formula-100 are the standard formula recommended by WHO to treat severely malnourished children. Receives: Other: Formula-75/Formula-100 |
| High Energy Oral Nutrition Supplement | Experimental | 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. Receives: Other: High Energy Oral Nutrition Supplement |
| Standard Energy Oral Nutrition Supplement | Experimental | 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. Receives: Other: Standard Energy Oral Nutrition Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal tolerance for bowel movement
Frequency of bowel movement per day and description of stool consistency (Bristol stool chart)
Measured: 14 days
Gastrointestinal tolerance for vomit
Frequency of vomit per day and volume of vomit
Measured: 14 days
Secondary outcomes (6)
Weight gain
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.
Measured: 14 days
Height gain
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.
Measured: 14 days
Prevalence of hypokalemia
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.
Measured: Day 1 and day 3
Prevalence of hypophosphatemia
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).
Measured: Day 1 and day 3
Prevalence of hypomagnesemia
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).
Measured: Day 1 and day 3
Changes of plasma amino acid concentration
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.
Measured: Day 1 and day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start4 Sep 2019
- Primary completion15 Apr 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute MalnutritionStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- PT. Nutricia Medical Nutrition
- Responsible party
- Principal investigator, Klara Yuliarti, Universitas Indonesia
- Investigators
- Klara Yuliarti, MD, Principal investigator, Department of Pediatric, Faculty of Medicine, University of Indonesia/ Cipto Mangunkusumo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715204
- Sponsor's protocol ID
- 19-04-0406
- Status last verified
- Dec 2021
- First submitted
- 12 Jan 2021
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04715204
- Acronym / sponsor ID
- 19-04-0406
- Conditions
- Severe Acute Malnutrition
- Keywords
- severe acute malnutrition, oral nutrition supplement, Formula-75/Formula-100, Under-five children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- PT. Nutricia Medical Nutrition
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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
- 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.
- On the second day: patient is given 75-90% of RDA as F75/standard energy ONS/high energy ONS.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Formula-75/Formula-100 | Active comparator | Other: Formula-75/Formula-100This arm is the control. Formula-75/Formula-100 are the standard formula recommended by WHO to treat severely malnourished children. |
| High Energy Oral Nutrition Supplement | Experimental | Other: High Energy Oral Nutrition SupplementHigh 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. |
| Standard Energy Oral Nutrition Supplement | Experimental | Other: Standard Energy Oral Nutrition SupplementStandard 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. |
Who may qualify
- Ages
- 12 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 12-60 months
- Weight for length/height z score < -3 (WHO 2006)
- Not on nutritional treatment of severe acute malnutrition for the last 1 month
Key exclusion criteria (3 listed)
- Not willing to take part in this study
- Having diarrhea
- Diagnosed with malignancy or suspected malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Energy Oral Nutrition SupplementAlso: High Energy ONSOral 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 | High Energy Oral Nutrition Supplement |
| Standard Energy Oral Nutrition SupplementAlso: Standard Energy ONSOral 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 | Standard Energy Oral Nutrition Supplement |
| Formula-75/Formula-100Also: F75/F100Formula-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 | Formula-75/Formula-100 |
Primary outcome
Gastrointestinal tolerance for bowel movement
Time frame: 14 days
Frequency of bowel movement per day and description of stool consistency (Bristol stool chart)
Gastrointestinal tolerance for vomit
Time frame: 14 days
Frequency of vomit per day and volume of vomit
6 secondary outcomes
Weight gain
Time frame: 14 days
Height gain
Time frame: 14 days
Prevalence of hypokalemia
Time frame: Day 1 and day 3
Prevalence of hypophosphatemia
Time frame: Day 1 and day 3
Prevalence of hypomagnesemia
Time frame: Day 1 and day 3
Changes of plasma amino acid concentration
Time frame: Day 1 and day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klara Yuliarti, MD principal investigator
Department of Pediatric, Faculty of Medicine, University of Indonesia/ Cipto Mangunkusumo Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Energy Oral Nutrition Supplement, Standard Energy Oral Nutrition Supplement and Formula-75/Formula-100 in people with Severe Acute Malnutrition, run by Universitas Indonesia at 2 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal tolerance for bowel movement (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2021.