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

NCT07315295 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-01-02

No results posted yet for this study

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

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

Sponsors & Collaborators

  • ETH Zurich

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
54 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-23
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Kenya
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07315295 on ClinicalTrials.gov