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

December 18, 2025 updated by: Nicole Stoffel, ETH Zurich

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Kenya
    • Kwale County
      • Msambweni, Kwale County, Kenya
        • Recruiting
        • ETH/Oxford/JKUAT research facility
        • Contact:
  • Switzerland
      • Zurich, Switzerland, 8006
        • Not yet recruiting
        • ETH Zurich, Laboratory of Clinical Biopharmacy, Zurich, 8092
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Fractional Iron Absorption
Time Frame: Day 0
Day 0
Fractional Iron Absorption
Time Frame: Day 20
Day 20
Fractional Iron Absorption
Time Frame: Day 40
Day 40
Fractional Iron Absorption
Time Frame: Day 60
Day 60

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hemoglobin
Time Frame: Day 0
Iron status parameter
Day 0
Hemoglobin
Time Frame: Day 20
Iron status parameter
Day 20
Hemoglobin
Time Frame: Day 40
Iron status parameter
Day 40
Hemoglobin
Time Frame: Day 60
Iron status parameter
Day 60
Hemoglobin
Time Frame: Day 80
Iron status parameter
Day 80
Serum ferritin
Time Frame: Day 0
Iron status parameter
Day 0
Serum Ferritin
Time Frame: Day 20
Iron status parameter
Day 20
Serum Ferritin
Time Frame: Day 40
Iron status parameter
Day 40
Serum Ferritin
Time Frame: Day 60
Iron status parameter
Day 60
soluble transferrin receptor
Time Frame: Day 0
Iron status parameter
Day 0
soluble transferrin receptor
Time Frame: Day 20
Iron status parameter
Day 20
soluble transferrin receptor
Time Frame: Day 40
Iron status parameter
Day 40
soluble transferrin receptor
Time Frame: Day 60
Iron status parameter
Day 60
C-reactive protein
Time Frame: Day 0
inflammation status parameter
Day 0
C-reactive protein
Time Frame: Day 20
inflammation status parameter
Day 20
C-reactive protein
Time Frame: Day 40
inflammation status parameter
Day 40
C-reactive protein
Time Frame: Day 60
inflammation status parameter
Day 60
α₁-acid glycoprotein
Time Frame: Day 0
inflammation status parameter
Day 0
α₁-acid glycoprotein
Time Frame: Day 20
inflammation status parameter
Day 20
α₁-acid glycoprotein
Time Frame: Day 40
inflammation status parameter
Day 40
α₁-acid glycoprotein
Time Frame: Day 60
inflammation status parameter
Day 60
body weight
Time Frame: Day 0
Day 0
body weight
Time Frame: Day 20
Day 20
body weight
Time Frame: Day 40
Day 40
body weight
Time Frame: Day 60
Day 60
body height
Time Frame: Day 0
Day 0
body height
Time Frame: Day 20
Day 20
body height
Time Frame: Day 40
Day 40
body height
Time Frame: Day 60
Day 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ETH Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 23, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 2, 2026

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings