F50 Trial
Evaluating the safety and tolerability of lower-calorie therapeutic milk during early stabilisation of critically ill children with severe malnutrition.
Why this research began
Standard F75 provides substantial energy during stabilisation, but emerging critical-care evidence raises the question of whether slower early energy introduction may be safer for some very ill children.
What the study asks
Can reduced-calorie therapeutic milk be safely used during the most unstable phase of severe malnutrition?
How the research works
Phase I clinical trial comparing standard F75 with reduced-calorie F50 and F35 formulations. Essential nutritional components are retained while caloric delivery is reduced. Glucose monitoring is central because hypoglycaemia is a key safety concern.
Who contributes
Planned enrolment of 135 children. Once clinically stabilised, participants transition to higher-energy rehabilitation feeding.
Where it takes place
Clinical trial in children with severe malnutrition in Malawi.
Study objectives
Evaluate safety and tolerability of lower-calorie therapeutic milk.
Monitor glucose and other clinical safety indicators.
Generate evidence needed to design a larger outcomes trial.
Principal and contributing research team
Status and study timeline
- 01Phase I
- 02Recruitment and safety monitoring
- 03Stabilisation feeding
- 04Safety analysis
Participating and collaborating institutions
Publications and findings
task_altThis is an active early-phase safety study; findings will be shared after approved analysis and dissemination.
Selected publications will be linked after the study record has been verified and approved.
Related news, documents and contact
Related updates
No related public updates have been published yet.
Study documents
Approved protocols, public summaries and shareable study materials are published through the research resources library.
Browse research resources arrow_forwardResearch contact
Contact MNRG for collaboration, study information or approved document requests.
Contact the research team arrow_forwardWhy it matters
Establishing safety is essential before a larger trial can test whether reduced-calorie stabilisation improves survival.