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

NCT ID: NCT07315295

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-23

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Healthy children

Healthy children

Group Type ACTIVE_COMPARATOR

Iron absorption from RUTF on Day 0

Intervention Type OTHER

RUFT with 57Fe

Children with MAM/SAM

children with moderate or severe acute malnutrition

Group Type EXPERIMENTAL

Iron absorption from RUTF on Day 0

Intervention Type OTHER

RUFT with 57Fe

Treatment with RUTF for 80 days

Intervention Type DIETARY_SUPPLEMENT

Daily RUTF intake

Iron absorption from RUTF on Day 20

Intervention Type OTHER

RUFT with 57Fe

Iron absorption from RUTF on Day 40

Intervention Type OTHER

RUFT with 57Fe

Iron absorption from RUTF on Day 60

Intervention Type OTHER

RUFT with 57Fe

Interventions

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Iron absorption from RUTF on Day 0

RUFT with 57Fe

Intervention Type OTHER

Treatment with RUTF for 80 days

Daily RUTF intake

Intervention Type DIETARY_SUPPLEMENT

Iron absorption from RUTF on Day 20

RUFT with 57Fe

Intervention Type OTHER

Iron absorption from RUTF on Day 40

RUFT with 57Fe

Intervention Type OTHER

Iron absorption from RUTF on Day 60

RUFT with 57Fe

Intervention Type OTHER

Eligibility Criteria

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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

* Hemoglobin ≤7 g/dL
* Presence of acute medical conditions requiring inpatient management
Minimum Eligible Age

12 Months

Maximum Eligible Age

54 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ETH Zurich

OTHER

Sponsor Role lead

Responsible Party

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Nicole Stoffel

Assistantprofessor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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ETH/Oxford/JKUAT research facility

Msambweni, Kwale County, Kenya

Site Status RECRUITING

ETH Zurich, Laboratory of Clinical Biopharmacy, Zurich, 8092

Zurich, , Switzerland

Site Status NOT_YET_RECRUITING

Countries

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Kenya Switzerland

Central Contacts

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Suzane Nyilima, MSc

Role: CONTACT

+254702836210

Facility Contacts

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Suzane Nyilima

Role: primary

+254702836210

Prof. Dr. Stoffel

Role: primary

+41 44 632 83 93

Other Identifiers

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SAMI

Identifier Type: -

Identifier Source: org_study_id

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