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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anemia; Malnutrition in Children; Iron Absorption; Severly Acutely Malnourished Children; Iron Deficiencies
• Intervention / Treatment: Other: Iron absorption from RUTF on Day 0; Dietary supplement: Treatment with RUTF for 80 days; Other: Iron absorption from RUTF on Day 20; Other: Iron absorption from RUTF on Day 40; Other: Iron absorption from RUTF on Day 60

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suzane Nyilima, MSc; Phone Number: +254702836210; Email: suzane.nyilima@gmail.com

Study Locations

• Kenya
  • Kwale County
    • Msambweni, Kwale County, Kenya
      • Recruiting
      • ETH/Oxford/JKUAT research facility
      • Contact: Suzane Nyilima; Phone Number: +254702836210; Email: suzane.nyilima@gmail.com
• Switzerland
  • Zurich, Switzerland, 8006
    • Not yet recruiting
    • ETH Zurich, Laboratory of Clinical Biopharmacy, Zurich, 8092
    • Contact: Prof. Dr. Stoffel; Phone Number: +41 44 632 83 93; Email: nicole.stoffel@pharma.ethz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

malnourished children:

• severe acute malnutrition (SAM): WHZ < -3.0
• moderate acute malnutrition (MAM): WHZ < -2.0 a
• treated as outpatients (no acute medical conditions and a positive appetite test)

healthy children:

- healthy: HAZ, WAZ and WHZ = 0

Exclusion Criteria (both groups):

• Hemoglobin ≤7 g/dL
• Presence of acute medical conditions requiring inpatient management

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy children	Other: Iron absorption from RUTF on Day 0; RUFT with 57Fe
Experimental: Children with MAM/SAM; children with moderate or severe acute malnutrition	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fractional Iron Absorption	Day 0
Fractional Iron Absorption	Day 20
Fractional Iron Absorption	Day 40
Fractional Iron Absorption	Day 60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin	Iron status parameter	Day 0
Hemoglobin	Iron status parameter	Day 20
Hemoglobin	Iron status parameter	Day 40
Hemoglobin	Iron status parameter	Day 60
Hemoglobin	Iron status parameter	Day 80
Serum ferritin	Iron status parameter	Day 0
Serum Ferritin	Iron status parameter	Day 20
Serum Ferritin	Iron status parameter	Day 40
Serum Ferritin	Iron status parameter	Day 60
soluble transferrin receptor	Iron status parameter	Day 0
soluble transferrin receptor	Iron status parameter	Day 20
soluble transferrin receptor	Iron status parameter	Day 40
soluble transferrin receptor	Iron status parameter	Day 60
C-reactive protein	inflammation status parameter	Day 0
C-reactive protein	inflammation status parameter	Day 20
C-reactive protein	inflammation status parameter	Day 40
C-reactive protein	inflammation status parameter	Day 60
α₁-acid glycoprotein	inflammation status parameter	Day 0
α₁-acid glycoprotein	inflammation status parameter	Day 20
α₁-acid glycoprotein	inflammation status parameter	Day 40
α₁-acid glycoprotein	inflammation status parameter	Day 60
body weight		Day 0
body weight		Day 20
body weight		Day 40
body weight		Day 60
body height		Day 0
body height		Day 20
body height		Day 40
body height		Day 60

Collaborators and Investigators

• Sponsor: ETH Zurich

Study record dates

Study Major Dates

• Study Start (Estimated): December 23, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Estimated): January 2, 2026

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Stable isotopes; Iron bioavailability; Ready to use therapeutic foods (RUFTs); Severe acute malnutrition (SAM)
• Additional Relevant MeSH Terms: Nutrition Disorders; Metabolic Diseases; Hematologic Diseases; Iron Metabolism Disorders; Malnutrition; Nutritional and Metabolic Diseases; Hemic and Lymphatic Diseases; Severe Acute Malnutrition; Iron Deficiencies; Anemia; Child Nutrition Disorders; Therapeutics
• Other Study ID Numbers: SAMI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No