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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 4
Healthy Volunteers: t
View:

⁃ 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

Locations
Other Locations
Kenya
ETH/Oxford/JKUAT research facility
RECRUITING
Msambweni
Switzerland
ETH Zurich, Laboratory of Clinical Biopharmacy, Zurich, 8092
NOT_YET_RECRUITING
Zurich
Contact Information
Primary
Suzane Nyilima, MSc
suzane.nyilima@gmail.com
+254702836210
Time Frame
Start Date: 2025-12-23
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 68
Treatments
Active_comparator: Healthy children
Healthy children
Experimental: Children with MAM/SAM
children with moderate or severe acute malnutrition
Related Therapeutic Areas
Sponsors
Leads: ETH Zurich

This content was sourced from clinicaltrials.gov