Anemia, Iron Absorption, Iron Deficiencies, Malnutrition in Children, Severly Acutely Malnourished Children
Conditions
Keywords
Ready to use therapeutic foods (RUFTs), Severe acute malnutrition (SAM), Stable isotopes, Iron bioavailability
Brief 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.
Interventions
OTHERIron absorption from RUTF on Day 0
RUFT with 57Fe
DIETARY_SUPPLEMENTTreatment with RUTF for 80 days
Daily RUTF intake
OTHERIron absorption from RUTF on Day 20
RUFT with 57Fe
OTHERIron absorption from RUTF on Day 40
RUFT with 57Fe
OTHERIron absorption from RUTF on Day 60
RUFT with 57Fe
Sponsors
ETH Zurich
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 54 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fractional Iron Absorption | Day 0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum ferritin | Day 0 | Iron status parameter |
| Serum Ferritin | Day 20 | Iron status parameter |
| soluble transferrin receptor | Day 0 | Iron status parameter |
| Hemoglobin | Day 0 | Iron status parameter |
| α₁-acid glycoprotein | Day 0 | inflammation status parameter |
| body weight | Day 0 | — |
| body height | Day 0 | — |
| C-reactive protein | Day 0 | inflammation status parameter |
Countries
Kenya, Switzerland
Contacts
Primary ContactSuzane Nyilima, MSc
Outcome results
None listed