NCT07315295

Maximizing the Benefits of Iron in Ready-to-Use Therapeutic Foods for Malnourished Children in Kenya

Maximizing the Benefits of Iron in Ready-to-use Therapeutic Foods for Malnourished Children in Kenya

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: ETH Zurich · Academic / Other
• Sex: All
• Age: 12 Months – 54 Months
• Healthy volunteers: Accepted

Summary

Reports from the Kenya Red Cross Society (KRCS) in Kwale County, southern Kenya, indicate a limited impact of Ready-to-Use Therapeutic Foods (RUTFs) on malnutrition or anemia. The current RUTF formulation may have an excessively high iron content. In severely acutely malnourished (SAM) children, iron cannot be properly absorbed, leading to life-threatening diarrhea. The overall aim of this project is to develop an improved RUTF treatment that addresses acute malnutrition and anemia in children, ensuring both safety and efficacy. Specifically, to assess the impact of malnutrition on fractional iron absorption (FIA) from RUTFs in children, by comparing healthy children to those with acute malnutrition and by tracking changes in FIA in malnourished children over the course of treatment.

Conditions

• Iron Absorption
• Iron Deficiencies
• Severly Acutely Malnourished Children
• Malnutrition in Children
• Anemia

Interventions

Type	Name	Description
OTHER	Iron absorption from RUTF on Day 0	RUFT with 57Fe
DIETARY_SUPPLEMENT	Treatment with RUTF for 80 days	Daily RUTF intake
OTHER	Iron absorption from RUTF on Day 20	RUFT with 57Fe
OTHER	Iron absorption from RUTF on Day 40	RUFT with 57Fe
OTHER	Iron absorption from RUTF on Day 60	RUFT with 57Fe

Timeline

• Start date: 2025-12-23
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2026-01-02
• Last updated: 2026-01-02

Locations

2 sites across 2 countries: Kenya, Switzerland