SAMIImproved RUTF Treatment for Acute Malnutrition and Anemia in Children
This study aims to enhance the treatment for acute malnutrition and anemia in children using an improved formulation of Ready-to-Use Therapeutic Food (RUTF).
Iron absorption from RUTF on Day 0
+ Treatment with RUTF for 80 days
+ Iron absorption from RUTF on Day 20
Severe Acute Malnutrition+8
+ Iron Deficiencies
+ Anemia
Other Study
Summary
Study start date: December 23, 2025
Actual date on which the first participant was enrolled.This study focuses on improving Ready-to-Use Therapeutic Foods (RUTFs) used for treating malnourished children in Kenya, specifically in Kwale County. The current RUTFs are reported to have limited effectiveness in addressing malnutrition and anemia, possibly due to an excessively high iron content. When children are severely acutely malnourished (SAM), their bodies struggle to absorb iron, potentially leading to severe diarrhea. This study aims to create a safer and more effective RUTF treatment that combats both acute malnutrition and anemia in children. During the study, researchers will compare how well healthy children and those with acute malnutrition absorb iron from RUTFs. They will also track changes in iron absorption in malnourished children throughout their treatment. The study's primary goal is to understand the impact of malnutrition on the body's ability to absorb iron from RUTFs, which could potentially lead to improvements in the formulation of these therapeutic foods.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.68 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 12 to 54 Months
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
ETH/Oxford/JKUAT research facility
Msambweni, KenyaOpen ETH/Oxford/JKUAT research facility in Google MapsETH Zurich, Laboratory of Clinical Biopharmacy, Zurich, 8092
Zurich, Switzerland