Safety Trial of F-60 Among Children Hospitalized With SAM (NCT07752628) | Clinical Trial Compass
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Safety Trial of F-60 Among Children Hospitalized With SAM
Bangladesh320 participantsStarted 2026-07-01
Plain-language 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. 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.
Who can participate
Age range
6 Months – 59 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparing clinical and biochemical safety of F60 and F75
Timeframe: 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".
Trial details
NCT IDNCT07752628
SponsorInternational Centre for Diarrhoeal Disease Research, Bangladesh