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Safety Trial of F-60 Among Children Hospitalized With SAM
Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
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.
Official title: Safety Trial of F-60 Among Children Hospitalized With Severe Acute Malnutrition
Key Details
Gender
All
Age Range
6 Months - 59 Months
Study Type
INTERVENTIONAL
Enrollment
320
Start Date
2026-07-01
Completion Date
2027-12-31
Last Updated
2026-08-07
Healthy Volunteers
No
Interventions
F75 milk feeds
Standard 'F75' (77 kcal/100 ml) provides 95 kcal/kg/day
F60 milk feeds
F-60 contains 60 kcal/100ml, and provides 78 kcal/kg/day
Locations (1)
Icddr,B
Dhaka, Bangladesh