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

ETH Zurich

Status: Enrolling

Conditions: Anemia; Malnutrition in Children; Iron Deficiencies; Iron Absorption; Severly Acutely Malnourished Children

Treatments: Other: Iron absorption from RUTF on Day 20; Dietary Supplement: Treatment with RUTF for 80 days; Other: Iron absorption from RUTF on Day 60; Other: Iron absorption from RUTF on Day 40; Other: Iron absorption from RUTF on Day 0

Study type: Interventional

Funder types: Other

Identifiers

NCT07315295

SAMI

Details and patient eligibility

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.

Enrollment: 68 estimated patients

Sex: All

Ages: 12 to 54 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 (both groups):

• Hemoglobin ≤7 g/dL
• Presence of acute medical conditions requiring inpatient management

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Healthy children

Active Comparator group

Description:

Healthy children

Treatment:

Other: Iron absorption from RUTF on Day 0

Children with MAM/SAM

Experimental group

Description:

children with moderate or severe acute malnutrition

Treatment:

Other: Iron absorption from RUTF on Day 0

Other: Iron absorption from RUTF on Day 40

Other: Iron absorption from RUTF on Day 60

Dietary Supplement: Treatment with RUTF for 80 days

Other: Iron absorption from RUTF on Day 20