A Phase 1 interventional study of F75 milk feeds and F50 milk feeds in Malnutrition, Severe Acute, Malnutrition, Child and Malnutrition, Infant, sponsored by The Hospital for Sick Children. Active, not recruiting at 2 sites in 2 countries. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by The Hospital for Sick Children · Phase 1, Interventional, and Treatment
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Among 11 studies in Severe Acute Malnutrition with a site in Bangladesh — 3 open to participants now, 4 under way, 1 of them phase 3. Severe Acute Malnutrition · Bangladesh.
Among the 11 studies in Severe Acute Malnutrition with a site in Bangladesh, this one is the 7th largest by planned enrollment of the 10 interventional ones that give a count, is the only one that started in 2025, is the only one in phase 1, and was the 10th registered.
82 studies on the registry are indexed under Severe Acute Malnutrition; 11 are open to participants now.
Browse Severe Acute Malnutrition studies →3 of the 11 studies in Severe Acute Malnutrition with a site in Bangladesh are open now. Recruiting first, the newest first:
International Centre for Diarrhoeal Disease Research, Bangladesh · Sites in Bangladesh
Ages 1 mo–59 mo
International Centre for Diarrhoeal Disease Research, Bangladesh · Sites in Bangladesh
Ages 6 mo–59 mo
International Centre for Diarrhoeal Disease Research, Bangladesh · Sites in Bangladesh
Ages 6 mo–24 mo
A study can be open while its sites in Bangladesh have not opened yet or have stopped. Only those recruiting at a site in Bangladesh →
Of the 7 Severe Acute Malnutrition studies recruiting now, none set no upper age limit and 7 stop at 75 or younger; 7 take children under 18; 3 take healthy volunteers.
This study: 6 Months to 59 Months · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 3 · Phase 3 3
First in 2009; this study’s year is marked. 1 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 135 is below the median of 400 across 69 interventional studies indexed under Severe Acute Malnutrition.
Median enrollment 240 across the 10 interventional studies, 473 across the 1 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
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None of the 11 has an industry lead sponsor. The 3 most frequent:
The Hospital for Sick Children is the lead sponsor of 578 studies on the registry; 83 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
The Hospital for Sick Children has 4 studies filed under Severe Acute Malnutrition — fewer than ten, so there is no comparison to draw.
1 of the studies in Severe Acute Malnutrition with a site in Bangladesh that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07752628International Centre for Diarrhoeal Disease Research, BangladeshSafety Trial of F-60 Among Children Hospitalized With SAM | 2027-09-30 |
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Among the 11 studies in Severe Acute Malnutrition with a site in Bangladesh, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The goal of this clinical trial is to learn if giving lower calorie feeds during the first stage of treatment helps improve survival in severely malnourished children who are ill. The main question it aims to answer is:
Is it safe to feed ill severely malnourished children lower calorie feeds during the early treatment phase?
Researchers will compare two lower calorie feeds (F50 and F35) to the standard feed (F75) to see if they help children recover safely without increasing their risk of low blood sugar (hypoglycemia).
Participants will:
Malnutrition is a leading cause of death, contributing to nearly 45% of all deaths in children under the age of 5 years worldwide. In its most severe form, severe malnutrition remains prevalent globally affecting more than 45 million children. Severely malnourished children have a strongly increased risk of death from common infectious diseases. Updates in treatment protocols for severe malnutrition have been the most impactful intervention against childhood mortality.
Management of severely malnourished children hospitalized with critical illness is based on guidelines developed by the World Health Organization and consists of three main components: 1. Clinical stabilization 2. Treatment of underlying infections 3. Nutritional rehabilitation. Clinical stabilization includes administration of broad-spectrum antibiotics, fluid resuscitation (if needed) and providing a nutritional stabilization feed that is called 'F75'. F75 was designed in the 1990's assuming that severely malnourished children with infections are metabolically vulnerable and have a range of micronutrient disturbances. F75 aims to provide 95 kcal/kg/day and was not intended for weight gain since, during this initial period, children are actively fighting infections. Once clinically stabilized, on average after 3-5 days, children are transitioned from F75 to ready-to-use therapeutic foods (RUTF) that provide a substantially higher amount of protein and calories to promote rapid weight gain. Some children fail this transition and have to revert back to F75 for a period of time due to clinical deterioration or not tolerating the RUTF. Despite protocolized management of these highly vulnerable patients, mortality rates have remained high over the past decades and reported to range between 10-30%, depending on population, setting and duration of follow up.
Scientific evidence from the last decade has started to reform the approach to care for critically ill children in relation to feeding. Evidence shows that, during severe infection, the body enters a catabolic state, which is critical for immune function and pathogen clearance. Overfeeding during this phase may disrupt essential metabolic processes, including a process of cellular recycling called autophagy, which play a key role in fighting infections. Studies in both high- and low-resource settings have shown that limiting caloric intake in the early days of critical illness may improve clinical outcomes, including reducing the risk of infections and decreasing ICU stay durations.
No clinical trial has examined the optimal caloric intake for ill severely malnourished children in LMIC and the current F75 composition was only based on expert opinion. Our population and treatment settings are substantially different compared to high income settings. Children in LMIC are often wasted to a degree of severity not frequently observed in high resource settings. Severely malnourished children are thought to be at risk of refeeding syndrome, defined as an acute insulin response to rapid refeeding leading to electrolyte imbalances and hypoglycemia. In many LMIC, health resources are scarce and physician and nurse to patient ratios are low. Malnourished children are therefore managed using relatively protocolized but largely non-evidence-based approaches. This has led the World Health Organization (WHO) to press the scientific community to review of current practices. Intravenous fluid administration is often avoided due to the absence of fluid solutions, infusion pumps and lack of resources to monitor fluid intake. Parenteral nutrition is generally not available. Therefore, fluid and nutrition are mainly provided orally or through a nasogastric tube.
We aim to test the safety and tolerability of using lower caloric feeds during the initial clinical stabilization phase of acutely ill severely malnourished children. Reducing caloric intake has been shown to improve clinical outcomes of critically ill children with malnutrition in high resource setting. We propose that applying a similar strategy during the initial stabilization phase will improve survival of critically ill children with malnutrition in low resource settings. However, reducing caloric intake in these children may increase the risk of hypoglycemia. Therefore, we will conduct a randomized phase I clinical trial specifically designed to assess and minimize this risk. The potential benefits on childhood survival renders this trial ethically and clinically justified. Given current data, the use of lower caloric feeds should be evaluated in this vulnerable population. Conducting this safety phase-I trial will be a critical step before proceeding with an efficacy-focused trial powered for mortality.
The F50 and F35 feeds have been meticulously formulated for this trial. Their composition is identical to that of F75, with the only distinction being the reduction in calorie content with F50 aiming to provide 63kcal/kg/day and F35 aiming to provide 47kcal/kg/day. This ensures that the nutritional parameters and essential components remain consistent, while the lower calorie count aligns with the specific requirements of this trial. Once clinically stabilized, on average after 3-5 days, children are transitioned from F50 or F35 to RUTF that provide substantially higher amounts of protein and calories to promote rapid weight gain. This novel trial design will be used to ensure the highest level of safety. Once the optimal and safe reduction in calories is determined, we would be able to perform a large intervention trial whereby the provided feeds (i.e., standard F75 or a reduced calorie feed) can be randomized and tested for efficacy in reducing mortality. This work has the potential to radically change how we manage seriously ill severely malnourished children and reduce the mortality in the most vulnerable children globally.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Clinical/Lab Feature \& Criteria Guidelines
Clinical/Lab Feature: Respiratory distress Oxygenation Criteria: "Subcostal in-drawing" or "nasal flaring" or "head-nodding"
Clinical/Lab Feature: Oxygenation Criteria: "Central cyanosis" or SaO2 \<90%
Clinical/Lab Feature: Circulation Criteria: Limb temperature gradient or capillary refill >3 seconds
Clinical/Lab Feature: Reduced conscious level Criteria: AVPU \< "A"
Clinical/Lab Feature: Rapid pulse Criteria: Heartbeat per min > 180
Clinical/Lab Feature: Severe anemia Criteria: \< 7g/dl
Clinical/Lab Feature: Hypoglycemia Criteria: Blood glucose \< 3mmol/L
Clinical/Lab Feature: Abnormal temperature Criteria: Axial temperature \<36 or >38oC
Clinical/Lab Feature: Very low MUAC Criteria: MUAC \<11cm
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
F-75 nutritional stabilization feed was designed in the 1990s assuming that severely malnourished children with infections are metabolically vulnerable and have a range of micronutrient disturbances. F75 aims to provide 95 kcal/kg/day and was intended to support children through early stabilization when fighting infections and not aimed at weight gain. Once clinically stabilized, on average after 3-5 days, children are transitioned from F75 to ready-to-use therapeutic foods (RUTF) that provide substantially higher amount of protein and calories to promote rapid weight gain.
Dietary Supplement: F75 milk feeds
The F50 feed has been meticulously formulated by Nutriset. The composition is identical to that of F75, with the only distinction being the reduction in calorie content with F50 aiming to provide 63kcal/kg/day. This ensures that the nutritional parameters and essential components remain consistent, while the lower calorie count aligns with the specific requirements of this trial. Once clinically stabilized, on average after 3-5 days, children are transitioned from F50 to RUTF that provide substantially higher amounts of protein and calories to promote rapid weight gain.
Dietary Supplement: F50 milk feeds
The F35 feed has been meticulously formulated by Nutriset. Their composition is identical to that of F75, with the only distinction being the reduction in calorie content with F35 aiming to provide 47kcal/kg/day. This ensures that the nutritional parameters and essential components remain consistent, while the lower calorie count aligns with the specific requirements of this trial. Once clinically stabilized, on average after 3-5 days, children are transitioned from F35 to RUTF that provide substantially higher amounts of protein and calories to promote rapid weight gain.
Dietary Supplement: F35 milk feeds
Standard 'F75' (75 kcal/100 ml) 95 kcal/kg/day 12.05 mg/kg/min glucose
Also known as: Therapeutic Milk
Reduced caloric 'F50' (50kcal/100ml) 63 kcal/kg/day 8.03mg/kg/min glucose
Also known as: Therapeutic Milk
Reduced caloric 'F35' (35 kcal/100ml) * 47 kcal/kg/day * 5.62 mg/kg/min glucose
Also known as: Therapeutic Milk
Episodes of moderate hypoglycemia
The occurrence of at least one episode of moderate hypoglycemia (less than or equal to 3.0 mmol/l) during the stabilization phase as measured utilizing the Dexcom Continous Glucose Monitoring Device and/or bed-side glucometer (OneTouch).
Time frame: During the period of F75/F50/F35 provision meaning the stabilization phase which is on average 3 days
Serious Adverse Events
The number of severe adverse events between the intervention (F50 and F35) and control (F75) arms. Diagnosis, date and time of onset, outcome severity and relation to the type of feed administration will be established within 24 hours and reported.
Time frame: During the period of F75/F50/F35 provision meaning the stabilization phase, which is on average 3 days
Episodes of hypoglycemia or hyperglycemia
The number of episodes of hypoglycemia (less than or equal to 3.0mmol/l) or hyperglycemia (greater than or equal to 10 mmol/l) and glycemic variability between the intervention (F50 and F35) and control (F75) arms. Measurements will be done utilizing the Dexcom Continuous Glucose Monitoring Device and/or bed-side glucometer (OneTouch).
Time frame: During the period of F75/F50/F35 provision meaning the stabilization phase, which is on average 3 days
Duration of the stabilization phase
The duration of the stabilization phase in days - including when the child "failed to transition" between the intervention (F50 and F35) and control (F75) arms.
Time frame: The duration of the stabilization phase which is expected to be on average 3 days following enrolment.
Failed transition to ready-to-use-therapeutic foods (RUTF).
Return to stabilization feed after attempting to introduce RUTF.
Time frame: Transition phase expected to be on average 3 days following start of RUTF
Duration of hospital stay
Length of time spent in hospital for the duration of the study
Time frame: Study enrolment to discharge, which is on average 7 days
Volume of feed consumed per day
Compare the volume of feeds consumed per day in ml/kg body weight for the interventions (F50 and F35) and control (F75) arms.
Time frame: During the period of the stabilization phase, which is on average 3 days
Change in weight
Change in weight from admission to clinical stabilization as determined by anthropometric measurements
Time frame: Admission to clinical stabilization, which is on average 3 days
Loose or watery stools
The number of loose or watery stools per day, using the Bristol Stool Scale.
Time frame: Study enrolment to discharge, which is on average 7 days
Vomiting episodes
Number of vomiting episodes per day
Time frame: Study enrolment to discharge, which is on average 7 days
Feeds withheld
Number of feeds withheld from participant
Time frame: During the period of the stabilization phase, which is on average 3 days
New Infection
New infection onset as defined by positive bacterial cultures
Time frame: Study enrolment to discharge, which is on average 7 days
Mortality
Mortality as a number and percentage during hospitalization.
Time frame: Study enrolment to discharge, which is on average 7 days
Glucose response
Pre and post prandial glucose response
Time frame: The duration of the stabilization phase, which is on average 3 days
C-reactive protein and white blood cell count and differential
C-reactive protein and white blood cell count and differential at enrolment as a biochemical marker of infection severity
Time frame: Enrolment
Venous blood gas, lactate, electrolytes
Venous blood gas, lactate, electrolytes at day 3 after hospital admission as a biochemical marker of illness severity and refeeding syndrome
Time frame: Day 3 of admission
Energy expenditure
Energy expenditure using Indirect Calorimetry at enrolment and day 1 after discharge
Time frame: Day 1 of admission and discharge, which is expected to be on average after 7 days
Plan to share: No — Only SAE's will be shared as individual participant data to the SAE review committee.
Started Feb 2025 (actual). Primary completion is estimated for May 2026, 15 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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