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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-54
SponsorETH Zurich

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

Hemoglobin ≤7 g/dL

Presence of acute medical conditions requiring inpatient management

Trial design

Design model

Parallel

Treatments tested in this trial

  • Iron absorption from RUTF on Day 0

    Other intervention

    RUFT with 57Fe

  • Treatment with RUTF for 80 days

    Dietary supplement

    Daily RUTF intake

  • Iron absorption from RUTF on Day 20

    Other intervention

    RUFT with 57Fe

  • Iron absorption from RUTF on Day 40

    Other intervention

    RUFT with 57Fe

  • Iron absorption from RUTF on Day 60

    Other intervention

    RUFT with 57Fe

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: Healthy childrenActive comparator 1 intervention
Group B: Children with MAM/SAMExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Fractional Iron Absorption

Time frame
Day 0
2

Fractional Iron Absorption

Time frame
Day 20
3

Fractional Iron Absorption

Time frame
Day 40
4

Fractional Iron Absorption

Time frame
Day 60

Secondary outcomes

1

Hemoglobin

Iron status parameter

Time frame
Day 0
2

Hemoglobin

Iron status parameter

Time frame
Day 20
3

Hemoglobin

Iron status parameter

Time frame
Day 40
4

Hemoglobin

Iron status parameter

Time frame
Day 60

Other outcomes

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