Actively Recruiting

Phase Not Applicable
Age: 12Months - 54Months
All Genders
Healthy Volunteers
NCT07315295

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

Led by ETH Zurich · Updated on 2026-01-02

68

Participants Needed

2

Research Sites

27 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 12Months - 54Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged between 1 and 4.5 years
  • Children with severe acute malnutrition (weight-for-height Z-score less than -3.0)
  • Children with moderate acute malnutrition (weight-for-height Z-score less than -2.0)
  • Children treated as outpatients with no acute medical conditions and a positive appetite test
  • Healthy children with height-for-age, weight-for-age, and weight-for-height Z-scores equal to 0
Not Eligible

You will not qualify if you...

  • Hemoglobin level less than 7 g/dL
  • Presence of acute medical conditions requiring inpatient treatment

AI-Screening

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Trial Site Locations

Total: 2 locations

1

ETH/Oxford/JKUAT research facility

Msambweni, Kwale County, Kenya

Actively Recruiting

2

ETH Zurich, Laboratory of Clinical Biopharmacy, Zurich, 8092

Zurich, Switzerland, 8006

Not Yet Recruiting

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Research Team

S

Suzane Nyilima, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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