Dietary SupplementationNCT07752628
Safety Trial of F-60 Among Children Hospitalized With SAM
A study testing F75 milk feeds and F60 milk feeds in people with Dietary Supplementation and Severe Acute Malnutrition, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
The current WHO-recommended F-75 diet for stabilization of SAM has remained largely unchanged since its development in the 1990s. No clinical trial has studied enhanced therapeutic formulas during the stabilization phase, particularly in high-burden, low-resource settings. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Dietary Supplementation, Severe Acute Malnutrition, Children
- What is being tested?
- F75 milk feeds and F60 milk feeds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jul 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6 to 59 months.
- Severe Acute Malnutrition (WHZ <-3 z-scores of the median WHO growth standards and/or MUAC <11.5 cm or bilateral pitting nutritional edema).
- Received a maximum of 2 feeds of F75 (or milk suzi) at the time of enrolment.
- Primary caregiver is able to provide written or witnessed informed consent.
Who cannot join
- Congenital heart disease
- A known or suspected diagnosis of tuberculosis at the time of screening
- Anatomic abnormalities of the gastrointestinal tract
- Cancer
- Spastic cerebral palsy, hydrocephalus,
- Haemoglobinopathies.
Show all 9Show fewer
- Children weigh more than 16 kg
- Diarrhea lasting more than 14 days prior to hospitalization.
- Children who require invasive critical care (ie, mechanical ventilation, continuous positive airway pressure (CPAP) >5 cm H2O, or >1 inotrope for BP support) will be ineligible. Informed written consent will be obtained from the child's guardian, following local practices.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety Trial of F-60 Among Children Hospitalized With Severe Acute Malnutrition
The current WHO-recommended F-75 diet for stabilization of SAM has remained largely unchanged since its development in the 1990s. No clinical trial has studied enhanced therapeutic formulas during the stabilization phase, particularly in high-burden, low-resource settings. Additionally, the current F75 nutritional formula was based only on expert opinion, not scientific evidence.
Evidence suggests that modifying the nutrient profile of stabilization formulas may improve survival, reduce complications such as refeeding syndrome, and enhance early recovery. A better stabilization formula for these medically fragile children has the potential to reduce mortality. The purpose of this randomized controlled clinical trial (RCT) is to test the hypothesis that an enhanced nutrient fortified therapeutic stabilization formula (F-60) will improve outcomes for children hospitalized with SAM, relative to the current standard of care (F-75).
Read more
Hypothesis: The main hypothesis of this safety study is that F-60 is not inferior to F-75.
Objectives:
To test this hypothesis, Investigators will pursue two specific aims. Aim 1: to assess laboratory outcomes in children stabilized with F-60. Aim 2: to assess clinical outcomes in children who receive F-60.
Read the detailed description
Outcomes for children with SAM have improved over the past 20 years. Community-based treatment programs and RUTF are making an impact. However, outcomes lag for hospitalized children with SAM. In many settings, more than 10% of these children die. Inpatient outcomes for children with SAM may be improved by more precisely matching the nutritional composition of the formula that is provided during stabilization to the unique nutritional requirements of children hospitalized with SAM. Specifically, modifying the nutrient profile of stabilization formula may reduce mortality, by reducing risk for complications such as refeeding syndrome, while supporting earlier recovery.
Therapeutic formulas for treating SAM were developed gradually, over the course of several decades. A basic goal of stabilizing care is to limit subsequent risk for refeeding syndrome, which occurs most often when the extra energy and protein needed for catch-up growth are introduced. The current standard of care stabilization formula, F-75, was developed to replenish electrolytes and to correct metabolic abnormalities. F-75 was formalized by WHO in 1999. Since then, widening access to community-based treatment programs for SAM has altered patient volume and acuity on malnutrition wards. Fewer children are now hospitalized for SAM. However, the total global requirement for for F-75 continues to grow, with stockouts now increasingly frequent.This may be partly due to increased acuity and length of stay among children with SAM who need hospitalization. An improved stabilization formula has the potential to improve outcomes for these medically fragile children, while also reducing costs by shortening the average length of stay.
F-60 is a novel therapeutic formula intended, like F-75, for children with SAM who need inpatient stabilization. Data on the energy requirements and optimal nutrient composition of therapeutic feeds have remained limited since their original development in the 1980s-1990s. The nutritional profile of F-60 reflects recent clinical evidence and regulatory guidance ensuring consistency with the most current scientific and regulatory recommendations. F-60 contains less energy (60 kcal/100ml) than F-75 (77 kcal/100ml). F-60 also contains greater concentrations of particular vitamins, minerals, methyl donors, and amino acids. From a regulatory standpoint, F-60 is a 'formula for special medical purposes'. It has not yet been tested in children. In this respect, F-60 is an investigational product. Much has been learned about malnutrition since F-75 was conceptualized more than 40 years ago. In developed settings, strategies to prevent refeeding syndrome are now increasingly nuanced. The design of F-60 reflects these recent insights, including one-carbon dysfunction, intestinal barrier dysfunction, metabolic recovery and risk of refeeding syndrome.
The trial proposed here aims to assess the biochemical and clinical safety of F-60, relative to the current standard of care, F-75.
The nutrient profile of F-60 has been meticulously formulated for this trial. F-60 contains less energy than F-75, which provides 77 kcal/100 ml, exceeding the Codex maximum of 70 kcal/100 ml. (8) Total energy content of F-60 reflects the Codex minimum (60 kcal/100 ml). This change aims to match the measured median resting energy expenditure in most children with SAM (≈78 kcal/kg/day). The reduction of energy in F-60 is achieved mainly by reducing the carbohydrate content. F-60 is fortified with essential amino acids. F-60 contains more milk protein and five essential amino acids that are particularly limiting in the diets that are associated with SAM: lysine, methionine, cysteine, threonine, and tryptophan. F-60 contains greater concentrations of certain electrolytes relative to F-75. These changes are intended to reduce the risk of cardiac conduction disturbances by more quickly repleting diminished electrolyte stores, a frequent occurrence in SAM. Potassium deficiency is common in SAM. Potassium is increased in F-60. F-75 contains 145 mg of potassium per 100 ml. F-60 provides 200 mg per 100 ml. The total phosphorus content of F-60 is comparable, providing ~ 117 mg/kg/day. The increased phosphorous content of F-75 is designed to more effectively replenish phosphorus stores. Magnesium depletion increases risk for cardiac arrhythmias during refeeding. F-60 provides more magnesium (23.4 mg/kg/day) than F-75 (12.3 mg/kg/day), when children are treated with a standard feed volume (ie, 130 ml/kg/day). F-60 incorporates modest trace mineral adjustments. These changes aim to ensure comparable intake between children consuming F-75 and F-60. Some moderate increases in F-60 reflect the greater inclusion of milk powder in F-60, which contains multiple trace minerals. F-60 provides increased amounts of water-soluble vitamins; B vitamins and vitamin C. These changes aim to support quicker metabolic recovery during stabilization. Thiamine (B1) is increased in F-60. Acute thiamine deficiency causes severe morbidity. Riboflavin (B2) is increased in F-60. Riboflavin supports energy metabolism and plays a vital role in one-carbon movement by supporting folate regeneration. Vitamin B3 (nicotinamide) is increased in F-60. B3 content in F-60 is increased to levels shown to support immune function. Pantothenic Acid (B5) is increased in F-60. Pantothenic acid is required for the synthesis of coenzyme A and acyl carrier protein. Both are essential for lipid metabolism. Pyridoxine (B6) is increased in F-60, providing ~0.32 mg/kg/day. Biotin (B7) is increased in F-60. Biotin is a coenzyme for carboxylases involved in fatty acid metabolism and keratin synthesis. Folate (B9) is increased in F-60. Folate is essential for one-carbon metabolism. It supports the transfer of methyl groups in the folate cycle. Cobalamin (B12) is increased in F-60: It supports two key enzymes: methylmalonyl-CoA mutase and methionine synthase, both essential for energy metabolism and one-carbon flux. Vitamin C is increased in F-60. Children who develop SAM often consume diets largely devoid of fresh fruits and vegetables, containing limited amounts of vitamin C. F-75 contains fat-soluble vitamins at levels adequate for age-specific nutritional requirements. F-60 preserves this standard for vitamins A, D, and E, with adjustments limited to ensuring intake that is comparable with F-75. In contrast, vitamin K content is increased in F-60. Carnitine, inositol, and taurine supplemented in F60 according to to current Codex Alimentarius guidelines. Choline is increased in F-60. The additional choline in F-60 aims to support cell membrane renewal, one-carbon function, and efficient energy metabolism during stabilization of SAM.
- Conditions
- Dietary Supplementation, Severe Acute Malnutrition, Children
- Being tested
- F75 milk feeds, F60 milk feeds
- Keywords
- enhanced therapeutic formula, stabilization phase, clinical trial, Under five children, malnutrition, Bangladesh
- Medical subject headings
- Severe Acute Malnutrition, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F75 milk feedsDietary supplement
Standard 'F75' (77 kcal/100 ml) provides 95 kcal/kg/day
F60 milk feedsDietary supplement
F-60 contains 60 kcal/100ml, and provides 78 kcal/kg/day
| Study group | Role | What they receive |
|---|---|---|
| F75 milk feeds | Active comparator | The WHO endorsed a standardized formulation of F-75 in the 1990s and energy density is 77 kcal/100ml. F75 aims to provide 95 kcal/kg/day and was intended to support children through early stabilization when fighting infections and is not aimed at weight gain. Receives: Dietary Supplement: F75 milk feeds |
| F60 milk feeds | Experimental | F-60 contains an energy density of 60 kcal/100ml. F-60 also contains greater concentrations of particular vitamins, minerals, methyl donors, and amino acids. Receives: Dietary Supplement: F60 milk feeds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing clinical and biochemical safety of F60 and F75
This trial will compare the safety of F-60 with F-75. The primary endpoint is a prespecified hierarchical composite outcome, comprised of biochemical and clinical parameters and a win-ratio. For this study, the term "biochemical" includes all laboratory indices. Examples of biochemical indices that will be collected in this study include blood glucose, phosphate, magnesium, liver function tests, serum pH, serum lactate, and CRP/procalcitonin. Clinical parameters include death, delayed transition to RUTF, a need for ICU care, clinical deterioration as evident by an increase in PEWS score, blood pressure, need for electrolyte replacement, and time until diarrhea resolution. Participants will be compared individually, according to each relevant parameter, in a predefined sequence. The methods of Finkelstein and Schoenfeld will be used to calculate a win-ratio. This hierarchical composite will serve as the primary outcome for assessing the safety of F-60 relative to F-75.
Measured: Primary outcome is a clinical composite consisting of clinical and laboratory-based parameters. Multiple outcomes included in this composite score will be recorded "from the time of randomization up until completion of hospitalization or up to 14 days".
Secondary outcomes (9)
Death during hospitalization
The study will compare all-cause inpatient mortality between the intervention (F-60) and control (F-75) arms.
Measured: The period of observation will extend from randomization until the time of discharge from the hospital. The average time frame will reflect "the average duration of hospitalization, 5-6 days, with most hospitalizations completed within 14 days".
Abnormal laboratory indices at 48 hours
Laboratory indices (e.g., serum sodium, potassium, glucose, phosphate, magnesium, albumin) are measured at baseline, again at 48 hours, and every 48 hours thereafter while children remain hospitalized and are receiving either the control (F-75) or intervention (F-60) product. Defining fixed measurement time points and a standardized set of laboratory parameters permits comparison of the intervention and control products at consistent points in time across a heterogeneous population of children and hospitalization courses.
Measured: Measured laboratory parameters will be assessed at 48 hours after randomization and then every 48 hours until scheduled lab draws cease, up to a maximum of 144 hours after randomization (e.g. < 7 days).
Time to Complete Transition to Ready-to-Use Therapeutic Food (RUTF)
Children with SAM who are unable to transition from their initial stabilization formula to ready-to-use therapeutic food often experience worsened outcomes. For this reason, time to complete the transition from stabilization formula to ready-to-use therapeutic food is identified as a clinically relevant secondary outcome. The total number of days needed to complete stabilization and transition to ready-to-use therapeutic food will be compared between the intervention and control arms. The average time frame to complete stabilization is expected to be four to five days; the maximum duration is expected to be seven days. A child who fails to complete transition to ready-to-use therapeutic food within seven days will be assigned an outcome of "delayed transition."
Measured: The average time frame to complete stabilization is expected to be 4 to 5 days. The maximum duration is 7 days, beyond which point a child who fails to complete transition to RUTF will be assigned an outcome of "delayed transition."
Time to resolve diarrhoea after enrollment
The number of loose stools a child experiences each day during hospitalization will be recorded. Diarrhea is defined as three or more loose stools within a 24-hour period.
Measured: The time until resolution of loose stools is expected to be less than 7 days (4 to 5 on average). Children whose diarrhea does not resolve before 7 days will be recorded as having prolonged diarrhea
Escalation of care to the ICU
Any child whose condition deteriorates to the extent that they require an escalation of care, requiring their transfer from a general pediatrics ward to an ICU setting, will be recorded as having met "escalation of care to ICU." The expected time frame includes the entire duration of hospitalization, the average of which is expected to be five to seven days, with nearly all children completing hospitalization within 21 days. Escalation of a child's care to an ICU setting will constitute a secondary outcome even when the child is no longer receiving one of the stabilization products.
Measured: The expected time frame of observation will be "from randomization to discharge, which is, on average, 7 days".
Hypoglycaemia during stabilization
Blood glucose less than 3 mmol/l by finger prick
Measured: From randomization until initiation of transition to ready to use therapeutic food, with an expected average observation time frame of 3 to 5 days.
Increase in PEWS score and low blood pressure
Pediatric early warning score (PEWS) and blood pressure will be assessed twice daily
Measured: From randomization to discharge, which is on average 7 days.
Hospital-acquired infection
Investigators will follow the patient twice daily during hospitalization, and Investigators will follow the standardized Hospital-acquired infection (HAI) definition to identify any new-onset infections after randomization and 3 days after discharge from the hospital.HAIs are infections that occur while receiving health care, are developed in a hospital or other health care facility, and that first appear 48 hours or more after hospital admission.
Measured: From "randomization to discharge, and any readmission within 3 days after discharge".
Need for electrolyte replacement
replacement of potassium, calcium, and magnesium
Measured: From randomization to 48 hours after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Jul 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Dietary SupplementationStudies of the same condition, open and under way.
- 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
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752628
- Sponsor's protocol ID
- PR- 25-014
- Status last verified
- Mar 2026
- First submitted
- 28 Jun 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only SAE's will be shared with DSMB as individual participant data
Publications
Tickell KD, Mangale DI, Tornberg-Belanger SN, Bourdon C, Thitiri J, Timbwa M, Njirammadzi J, Voskuijl W, Chisti MJ, Ahmed T, Shahid ASMSB, Diallo AH, Ouedrago I, Khan AF, Saleem AF, Arif F, Kazi Z, Mupere E, Mukisa J, Sukhtankar P, Berkley JA, Walson JL, Denno DM; Childhood Acute Illness and Nutrition Network. A mixed method multi-country assessment of barriers to implementing pediatric inpatient care guidelines. PLoS One. 2019 Mar 25;14(3):e0212395. doi: 10.1371/journal.pone.0212395. eCollection 2019.
PubMed 30908499Bandsma RHJ, Voskuijl W, Chimwezi E, Fegan G, Briend A, Thitiri J, Ngari M, Mwalekwa L, Bandika V, Ali R, Hamid F, Owor B, Mturi N, Potani I, Allubha B, Muller Kobold AC, Bartels RH, Versloot CJ, Feenstra M, van den Brink DA, van Rheenen PF, Kerac M, Bourdon C, Berkley JA. A reduced-carbohydrate and lactose-free formulation for stabilization among hospitalized children with severe acute malnutrition: A double-blind, randomized controlled trial. PLoS Med. 2019 Feb 26;16(2):e1002747. doi: 10.1371/journal.pmed.1002747. eCollection 2019 Feb.
PubMed 30807589Afroze F, Khoshnevisan F, Harawa PP, Islam Z, Bourdon C, Khoswe S, Islam M, Sarker SA, Islam F, Sayeem Bin Shahid ASM, Joosten K, Hulst JM, Eneya C, Walson JL, Berkley JA, Potani I, Voskuijl W, Ahmed T, Chisti MJ, Bandsma RHJ. Trajectories of resting energy expenditure and performance of predictive equations in children hospitalized with an acute illness and malnutrition: a longitudinal study. Sci Rep. 2024 Feb 13;14(1):3613. doi: 10.1038/s41598-024-53791-w.
PubMed 38351162Childhood Acute Illness and Nutrition (CHAIN) Network. Characterising paediatric mortality during and after acute illness in Sub-Saharan Africa and South Asia: a secondary analysis of the CHAIN cohort using a machine learning approach. EClinicalMedicine. 2023 Feb 6;57:101838. doi: 10.1016/j.eclinm.2023.101838. eCollection 2023 Mar.
PubMed 36825237Cussotto S, Delgado I, Anesi A, Dexpert S, Aubert A, Beau C, Forestier D, Ledaguenel P, Magne E, Mattivi F, Capuron L. Tryptophan Metabolic Pathways Are Altered in Obesity and Are Associated With Systemic Inflammation. Front Immunol. 2020 Apr 15;11:557. doi: 10.3389/fimmu.2020.00557. eCollection 2020.
PubMed 32351500Talbert A, Thuo N, Karisa J, Chesaro C, Ohuma E, Ignas J, Berkley JA, Toromo C, Atkinson S, Maitland K. Diarrhoea complicating severe acute malnutrition in Kenyan children: a prospective descriptive study of risk factors and outcome. PLoS One. 2012;7(6):e38321. doi: 10.1371/journal.pone.0038321. Epub 2012 Jun 4.
PubMed 22675542Sturgeon JP, Mufukari W, Tome J, Dumbura C, Majo FD, Ngosa D, Chandwe K, Kapoma C, Mutasa K, Nathoo KJ, Bourke CD, Ntozini R, Bwakura-Dangarembizi M, Amadi B, Kelly P, Prendergast AJ; HOPE-SAM study team. Risk factors for inpatient mortality among children with severe acute malnutrition in Zimbabwe and Zambia. Eur J Clin Nutr. 2023 Sep;77(9):895-904. doi: 10.1038/s41430-023-01320-9. Epub 2023 Aug 8.
PubMed 37553508Vresk L, Flanagan M, Daniel AI, Potani I, Bourdon C, Spiegel-Feld C, Thind MK, Farooqui A, Ling C, Miraglia E, Hu G, Wen B, Zlotkin S, James P, McGrath M, Bandsma RHJ. Micronutrient status in children aged 6-59 months with severe wasting and/or nutritional edema: implications for nutritional rehabilitation formulations. Nutr Rev. 2025 Jan 1;83(1):112-145. doi: 10.1093/nutrit/nuad165.
PubMed 38350491Baldeon ME, Zertuche F, Flores N, Fornasini M. Free Amino Acid Content in Human Milk is Associated with Infant Gender and Weight Gain during the First Four Months of Lactation. Nutrients. 2019 Sep 17;11(9):2239. doi: 10.3390/nu11092239.
PubMed 31533347Langendorf C, Roederer T, de Pee S, Brown D, Doyon S, Mamaty AA, Toure LW, Manzo ML, Grais RF. Preventing acute malnutrition among young children in crises: a prospective intervention study in Niger. PLoS Med. 2014 Sep 2;11(9):e1001714. doi: 10.1371/journal.pmed.1001714. eCollection 2014 Sep.
PubMed 25180584
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Trial of F-60 Among Children Hospitalized With Severe Acute Malnutrition
- ClinicalTrials.gov ID
- NCT07752628
- Acronym / sponsor ID
- PR- 25-014
- Conditions
- Dietary Supplementation, Severe Acute Malnutrition, Children
- Keywords
- enhanced therapeutic formula, stabilization phase, clinical trial, Under five children, malnutrition, Bangladesh
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Aug 2026 (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 current WHO-recommended F-75 diet for stabilization of SAM has remained largely unchanged since its development in the 1990s. No clinical trial has studied enhanced therapeutic formulas during the stabilization phase, particularly in high-burden, low-resource settings. Additionally, the current F75 nutritional formula was based only on expert opinion, not scientific evidence.
Evidence suggests that modifying the nutrient profile of stabilization formulas may improve survival, reduce complications such as refeeding syndrome, and enhance early recovery. A better stabilization formula for these medically fragile children has the potential to reduce mortality. The purpose of this randomized controlled clinical trial (RCT) is to test the hypothesis that an enhanced nutrient fortified therapeutic stabilization formula (F-60) will improve outcomes for children hospitalized with SAM, relative to the current standard of care (F-75).
Hypothesis: The main hypothesis of this safety study is that F-60 is not inferior to F-75.
Objectives:
To test this hypothesis, Investigators will pursue two specific aims. Aim 1: to assess laboratory outcomes in children stabilized with F-60. Aim 2: to assess clinical outcomes in children who receive F-60.
Detailed description
Outcomes for children with SAM have improved over the past 20 years. Community-based treatment programs and RUTF are making an impact. However, outcomes lag for hospitalized children with SAM. In many settings, more than 10% of these children die. Inpatient outcomes for children with SAM may be improved by more precisely matching the nutritional composition of the formula that is provided during stabilization to the unique nutritional requirements of children hospitalized with SAM. Specifically, modifying the nutrient profile of stabilization formula may reduce mortality, by reducing risk for complications such as refeeding syndrome, while supporting earlier recovery.
Therapeutic formulas for treating SAM were developed gradually, over the course of several decades. A basic goal of stabilizing care is to limit subsequent risk for refeeding syndrome, which occurs most often when the extra energy and protein needed for catch-up growth are introduced. The current standard of care stabilization formula, F-75, was developed to replenish electrolytes and to correct metabolic abnormalities. F-75 was formalized by WHO in 1999. Since then, widening access to community-based treatment programs for SAM has altered patient volume and acuity on malnutrition wards. Fewer children are now hospitalized for SAM. However, the total global requirement for for F-75 continues to grow, with stockouts now increasingly frequent.This may be partly due to increased acuity and length of stay among children with SAM who need hospitalization. An improved stabilization formula has the potential to improve outcomes for these medically fragile children, while also reducing costs by shortening the average length of stay.
F-60 is a novel therapeutic formula intended, like F-75, for children with SAM who need inpatient stabilization. Data on the energy requirements and optimal nutrient composition of therapeutic feeds have remained limited since their original development in the 1980s-1990s. The nutritional profile of F-60 reflects recent clinical evidence and regulatory guidance ensuring consistency with the most current scientific and regulatory recommendations. F-60 contains less energy (60 kcal/100ml) than F-75 (77 kcal/100ml). F-60 also contains greater concentrations of particular vitamins, minerals, methyl donors, and amino acids. From a regulatory standpoint, F-60 is a 'formula for special medical purposes'. It has not yet been tested in children. In this respect, F-60 is an investigational product. Much has been learned about malnutrition since F-75 was conceptualized more than 40 years ago. In developed settings, strategies to prevent refeeding syndrome are now increasingly nuanced. The design of F-60 reflects these recent insights, including one-carbon dysfunction, intestinal barrier dysfunction, metabolic recovery and risk of refeeding syndrome.
The trial proposed here aims to assess the biochemical and clinical safety of F-60, relative to the current standard of care, F-75.
The nutrient profile of F-60 has been meticulously formulated for this trial. F-60 contains less energy than F-75, which provides 77 kcal/100 ml, exceeding the Codex maximum of 70 kcal/100 ml. (8) Total energy content of F-60 reflects the Codex minimum (60 kcal/100 ml). This change aims to match the measured median resting energy expenditure in most children with SAM (≈78 kcal/kg/day). The reduction of energy in F-60 is achieved mainly by reducing the carbohydrate content. F-60 is fortified with essential amino acids. F-60 contains more milk protein and five essential amino acids that are particularly limiting in the diets that are associated with SAM: lysine, methionine, cysteine, threonine, and tryptophan. F-60 contains greater concentrations of certain electrolytes relative to F-75. These changes are intended to reduce the risk of cardiac conduction disturbances by more quickly repleting diminished electrolyte stores, a frequent occurrence in SAM. Potassium deficiency is common in SAM. Potassium is increased in F-60. F-75 contains 145 mg of potassium per 100 ml. F-60 provides 200 mg per 100 ml. The total phosphorus content of F-60 is comparable, providing ~ 117 mg/kg/day. The increased phosphorous content of F-75 is designed to more effectively replenish phosphorus stores. Magnesium depletion increases risk for cardiac arrhythmias during refeeding. F-60 provides more magnesium (23.4 mg/kg/day) than F-75 (12.3 mg/kg/day), when children are treated with a standard feed volume (ie, 130 ml/kg/day). F-60 incorporates modest trace mineral adjustments. These changes aim to ensure comparable intake between children consuming F-75 and F-60. Some moderate increases in F-60 reflect the greater inclusion of milk powder in F-60, which contains multiple trace minerals. F-60 provides increased amounts of water-soluble vitamins; B vitamins and vitamin C. These changes aim to support quicker metabolic recovery during stabilization. Thiamine (B1) is increased in F-60. Acute thiamine deficiency causes severe morbidity. Riboflavin (B2) is increased in F-60. Riboflavin supports energy metabolism and plays a vital role in one-carbon movement by supporting folate regeneration. Vitamin B3 (nicotinamide) is increased in F-60. B3 content in F-60 is increased to levels shown to support immune function. Pantothenic Acid (B5) is increased in F-60. Pantothenic acid is required for the synthesis of coenzyme A and acyl carrier protein. Both are essential for lipid metabolism. Pyridoxine (B6) is increased in F-60, providing ~0.32 mg/kg/day. Biotin (B7) is increased in F-60. Biotin is a coenzyme for carboxylases involved in fatty acid metabolism and keratin synthesis. Folate (B9) is increased in F-60. Folate is essential for one-carbon metabolism. It supports the transfer of methyl groups in the folate cycle. Cobalamin (B12) is increased in F-60: It supports two key enzymes: methylmalonyl-CoA mutase and methionine synthase, both essential for energy metabolism and one-carbon flux. Vitamin C is increased in F-60. Children who develop SAM often consume diets largely devoid of fresh fruits and vegetables, containing limited amounts of vitamin C. F-75 contains fat-soluble vitamins at levels adequate for age-specific nutritional requirements. F-60 preserves this standard for vitamins A, D, and E, with adjustments limited to ensuring intake that is comparable with F-75. In contrast, vitamin K content is increased in F-60. Carnitine, inositol, and taurine supplemented in F60 according to to current Codex Alimentarius guidelines. Choline is increased in F-60. The additional choline in F-60 aims to support cell membrane renewal, one-carbon function, and efficient energy metabolism during stabilization of SAM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F75 milk feeds | Active comparator | Dietary Supplement: F75 milk feedsThe WHO endorsed a standardized formulation of F-75 in the 1990s and energy density is 77 kcal/100ml. F75 aims to provide 95 kcal/kg/day and was intended to support children through early stabilization when fighting infections and is not aimed at weight gain. |
| F60 milk feeds | Experimental | Dietary Supplement: F60 milk feedsF-60 contains an energy density of 60 kcal/100ml. F-60 also contains greater concentrations of particular vitamins, minerals, methyl donors, and amino acids. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 6 to 59 months.
- Severe Acute Malnutrition (WHZ <-3 z-scores of the median WHO growth standards and/or MUAC <11.5 cm or bilateral pitting nutritional edema).
- Received a maximum of 2 feeds of F75 (or milk suzi) at the time of enrolment.
- Primary caregiver is able to provide written or witnessed informed consent.
Key exclusion criteria (9 listed)
- Congenital heart disease
- A known or suspected diagnosis of tuberculosis at the time of screening
- Anatomic abnormalities of the gastrointestinal tract
- Cancer
- Spastic cerebral palsy, hydrocephalus,
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 |
|---|---|---|
| F75 milk feedsStandard 'F75' (77 kcal/100 ml) provides 95 kcal/kg/day | Dietary supplement | F75 milk feeds |
| F60 milk feedsF-60 contains 60 kcal/100ml, and provides 78 kcal/kg/day | Dietary supplement | F60 milk feeds |
Primary outcome
Comparing clinical and biochemical safety of F60 and F75
Time frame: Primary outcome is a clinical composite consisting of clinical and laboratory-based parameters. Multiple outcomes included in this composite score will be recorded "from the time of randomization up until completion of hospitalization or up to 14 days".
This trial will compare the safety of F-60 with F-75. The primary endpoint is a prespecified hierarchical composite outcome, comprised of biochemical and clinical parameters and a win-ratio. For this study, the term "biochemical" includes all laboratory indices. Examples of biochemical indices that will be collected in this study include blood glucose, phosphate, magnesium, liver function tests, serum pH, serum lactate, and CRP/procalcitonin. Clinical parameters include death, delayed transition to RUTF, a need for ICU care, clinical deterioration as evident by an increase in PEWS score, blood pressure, need for electrolyte replacement, and time until diarrhea resolution. Participants will be compared individually, according to each relevant parameter, in a predefined sequence. The methods of Finkelstein and Schoenfeld will be used to calculate a win-ratio. This hierarchical composite will serve as the primary outcome for assessing the safety of F-60 relative to F-75.
9 secondary outcomes
Death during hospitalization
Time frame: The period of observation will extend from randomization until the time of discharge from the hospital. The average time frame will reflect "the average duration of hospitalization, 5-6 days, with most hospitalizations completed within 14 days".
Abnormal laboratory indices at 48 hours
Time frame: Measured laboratory parameters will be assessed at 48 hours after randomization and then every 48 hours until scheduled lab draws cease, up to a maximum of 144 hours after randomization (e.g. < 7 days).
Time to Complete Transition to Ready-to-Use Therapeutic Food (RUTF)
Time frame: The average time frame to complete stabilization is expected to be 4 to 5 days. The maximum duration is 7 days, beyond which point a child who fails to complete transition to RUTF will be assigned an outcome of "delayed transition."
Time to resolve diarrhoea after enrollment
Time frame: The time until resolution of loose stools is expected to be less than 7 days (4 to 5 on average). Children whose diarrhea does not resolve before 7 days will be recorded as having prolonged diarrhea
Escalation of care to the ICU
Time frame: The expected time frame of observation will be "from randomization to discharge, which is, on average, 7 days".
Hypoglycaemia during stabilization
Time frame: From randomization until initiation of transition to ready to use therapeutic food, with an expected average observation time frame of 3 to 5 days.
Increase in PEWS score and low blood pressure
Time frame: From randomization to discharge, which is on average 7 days.
Hospital-acquired infection
Time frame: From "randomization to discharge, and any readmission within 3 days after discharge".
Need for electrolyte replacement
Time frame: From randomization to 48 hours after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Background: PubMed 30908499Tickell KD, Mangale DI, Tornberg-Belanger SN, Bourdon C, Thitiri J, Timbwa M, Njirammadzi J, Voskuijl W, Chisti MJ, Ahmed T, Shahid ASMSB, Diallo AH, Ouedrago I, Khan AF, Saleem AF, Arif F, Kazi Z, Mupere E, Mukisa J, Sukhtankar P, Berkley JA, Walson JL, Denno DM; Childhood Acute Illness and Nutrition Network. A mixed method multi-country assessment of barriers to implementing pediatric inpatient care guidelines. PLoS One. 2019 Mar 25;14(3):e0212395. doi: 10.1371/journal.pone.0212395. eCollection 2019.
- Background: PubMed 30807589Bandsma RHJ, Voskuijl W, Chimwezi E, Fegan G, Briend A, Thitiri J, Ngari M, Mwalekwa L, Bandika V, Ali R, Hamid F, Owor B, Mturi N, Potani I, Allubha B, Muller Kobold AC, Bartels RH, Versloot CJ, Feenstra M, van den Brink DA, van Rheenen PF, Kerac M, Bourdon C, Berkley JA. A reduced-carbohydrate and lactose-free formulation for stabilization among hospitalized children with severe acute malnutrition: A double-blind, randomized controlled trial. PLoS Med. 2019 Feb 26;16(2):e1002747. doi: 10.1371/journal.pmed.1002747. eCollection 2019 Feb.
- Background: PubMed 38351162Afroze F, Khoshnevisan F, Harawa PP, Islam Z, Bourdon C, Khoswe S, Islam M, Sarker SA, Islam F, Sayeem Bin Shahid ASM, Joosten K, Hulst JM, Eneya C, Walson JL, Berkley JA, Potani I, Voskuijl W, Ahmed T, Chisti MJ, Bandsma RHJ. Trajectories of resting energy expenditure and performance of predictive equations in children hospitalized with an acute illness and malnutrition: a longitudinal study. Sci Rep. 2024 Feb 13;14(1):3613. doi: 10.1038/s41598-024-53791-w.
- Background: PubMed 36825237Childhood Acute Illness and Nutrition (CHAIN) Network. Characterising paediatric mortality during and after acute illness in Sub-Saharan Africa and South Asia: a secondary analysis of the CHAIN cohort using a machine learning approach. EClinicalMedicine. 2023 Feb 6;57:101838. doi: 10.1016/j.eclinm.2023.101838. eCollection 2023 Mar.
- Background: PubMed 32351500Cussotto S, Delgado I, Anesi A, Dexpert S, Aubert A, Beau C, Forestier D, Ledaguenel P, Magne E, Mattivi F, Capuron L. Tryptophan Metabolic Pathways Are Altered in Obesity and Are Associated With Systemic Inflammation. Front Immunol. 2020 Apr 15;11:557. doi: 10.3389/fimmu.2020.00557. eCollection 2020.
- Background: PubMed 22675542Talbert A, Thuo N, Karisa J, Chesaro C, Ohuma E, Ignas J, Berkley JA, Toromo C, Atkinson S, Maitland K. Diarrhoea complicating severe acute malnutrition in Kenyan children: a prospective descriptive study of risk factors and outcome. PLoS One. 2012;7(6):e38321. doi: 10.1371/journal.pone.0038321. Epub 2012 Jun 4.
- Background: PubMed 37553508Sturgeon JP, Mufukari W, Tome J, Dumbura C, Majo FD, Ngosa D, Chandwe K, Kapoma C, Mutasa K, Nathoo KJ, Bourke CD, Ntozini R, Bwakura-Dangarembizi M, Amadi B, Kelly P, Prendergast AJ; HOPE-SAM study team. Risk factors for inpatient mortality among children with severe acute malnutrition in Zimbabwe and Zambia. Eur J Clin Nutr. 2023 Sep;77(9):895-904. doi: 10.1038/s41430-023-01320-9. Epub 2023 Aug 8.
- Background: PubMed 38350491Vresk L, Flanagan M, Daniel AI, Potani I, Bourdon C, Spiegel-Feld C, Thind MK, Farooqui A, Ling C, Miraglia E, Hu G, Wen B, Zlotkin S, James P, McGrath M, Bandsma RHJ. Micronutrient status in children aged 6-59 months with severe wasting and/or nutritional edema: implications for nutritional rehabilitation formulations. Nutr Rev. 2025 Jan 1;83(1):112-145. doi: 10.1093/nutrit/nuad165.
- Background: PubMed 31533347Baldeon ME, Zertuche F, Flores N, Fornasini M. Free Amino Acid Content in Human Milk is Associated with Infant Gender and Weight Gain during the First Four Months of Lactation. Nutrients. 2019 Sep 17;11(9):2239. doi: 10.3390/nu11092239.
- Background: PubMed 25180584Langendorf C, Roederer T, de Pee S, Brown D, Doyon S, Mamaty AA, Toure LW, Manzo ML, Grais RF. Preventing acute malnutrition among young children in crises: a prospective intervention study in Niger. PLoS Med. 2014 Sep 2;11(9):e1001714. doi: 10.1371/journal.pmed.1001714. eCollection 2014 Sep.
- Individual participant dataSharing planned: No. Only SAE's will be shared with DSMB as individual participant data
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F75 milk feeds and F60 milk feeds in people with Dietary Supplementation and Severe Acute Malnutrition, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
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 4 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. 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?
This study is still under way. Results are not available in the source record yet.
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?
Comparing clinical and biochemical safety of F60 and F75 (time frame: Primary outcome is a clinical composite consisting of clinical and laboratory-based parameters. Multiple outcomes included in this composite score will be recorded "from the time of randomization up until completion of hospitalization or up to 14 days".). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07752628, which also lists 10 linked publications.
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 7 Aug 2026.