Actively Recruiting

Phase Not Applicable
Age: 12Months - 54Months
All Genders
Healthy Volunteers
ID07315295

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

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Reports from the Kenya Red Cross Society in Kwale County suggest that the current Ready-to-Use Therapeutic Foods (RUTFs) may have limited impact on malnutrition or anemia in children, possibly due to high iron content and poor iron absorption in severely acutely malnourished (SAM) children, which can cause dangerous diarrhea. This study aims to develop an improved RUTF treatment that addresses both acute malnutrition and anemia safely and effectively by assessing iron absorption in children with different nutritional statuses. The study compares healthy children with those suffering from moderate or severe acute malnutrition. Participants will receive RUTF containing a special form of iron (57Fe) to measure fractional iron absorption at multiple time points: Day 0, 20, 40, and 60. Malnourished children will undergo daily RUTF treatment for 80 days. The study tracks changes in iron absorption and nutritional status throughout this period. Participants will be monitored through measurements of fractional iron absorption, hemoglobin levels, serum ferritin, soluble transferrin receptor, inflammatory markers, body weight, and height at scheduled days from the start until Day 80. These assessments will help researchers understand how malnutrition affects iron absorption and how the RUTF treatment impacts anemia and overall health. The study period extends from December 2025 to June 2026.

CONDITIONS

Brief 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 month 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 normal height-for-age, weight-for-age, and weight-for-height measurements (Z-scores equal to 0)
Not Eligible

You will not qualify if you...

  • Hemoglobin level less than or equal to 7 g/dL
  • Presence of acute medical conditions requiring inpatient management

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 80 days

Participants receive daily Ready-to-Use Therapeutic Food (RUTF) for nutritional support over the course of 80 days.

Visits on Day 0, Day 20, Day 40, Day 60, and Day 80 for assessments

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

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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