Safety Trial of F-60 Among Children Hospitalized With SAM

Enrolling by invitation · Not applicable

Conditions studied: Dietary Supplementation, Severe Acute Malnutrition, Children

In brief

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.

Key facts

Study ID

NCT07752628

Run by

International Centre for Diarrhoeal Disease Research, Bangladesh

People needed

320

Starts

2026-07-01

Expected to finish

2027-12-31

Last updated by the study team

2026-08-07

Who can join

Age: 1 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Icddr,B — Dhaka, Bangladesh

Full record on ClinicalTrials.gov

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