NCT07315295

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Dec 2025Jun 2026

First Submitted

Initial submission to the registry

December 18, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

December 23, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 2, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

December 18, 2025

Last Update Submit

December 18, 2025

Conditions

AnemiaIron DeficienciesSeverly Acutely Malnourished ChildrenMalnutrition in ChildrenIron Absorption

Keywords

Ready to use therapeutic foods (RUFTs)Severe acute malnutrition (SAM)Stable isotopesIron bioavailability

Outcome Measures

Primary Outcomes (4)

  • Fractional Iron Absorption

    Day 0

  • Fractional Iron Absorption

    Day 20

  • Fractional Iron Absorption

    Day 40

  • Fractional Iron Absorption

    Day 60

Secondary Outcomes (29)

  • Hemoglobin

    Day 0

  • Hemoglobin

    Day 20

  • Hemoglobin

    Day 40

  • Hemoglobin

    Day 60

  • Hemoglobin

    Day 80

  • +24 more secondary outcomes

Study Arms (2)

Healthy children

ACTIVE COMPARATOR

Healthy children

Other: Iron absorption from RUTF on Day 0

Children with MAM/SAM

EXPERIMENTAL

children with moderate or severe acute malnutrition

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

Interventions

Iron absorption from RUTF on Day 0OTHER

RUFT with 57Fe

Children with MAM/SAMHealthy children
Treatment with RUTF for 80 daysDIETARY_SUPPLEMENT

Daily RUTF intake

Children with MAM/SAM
Iron absorption from RUTF on Day 40OTHER

RUFT with 57Fe

Children with MAM/SAM
Iron absorption from RUTF on Day 20OTHER

RUFT with 57Fe

Children with MAM/SAM
Iron absorption from RUTF on Day 60OTHER

RUFT with 57Fe

Children with MAM/SAM

Eligibility Criteria

Age12 Months - 54 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ETH/Oxford/JKUAT research facility

Msambweni, Kwale County, Kenya

RECRUITING

ETH Zurich, Laboratory of Clinical Biopharmacy, Zurich, 8092

Zurich, 8006, Switzerland

NOT YET RECRUITING

MeSH Terms

Conditions

Iron DeficienciesChild Nutrition DisordersAnemiaSevere Acute Malnutrition

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesNutrition DisordersHematologic DiseasesHemic and Lymphatic DiseasesMalnutrition

Central Study Contacts

Suzane Nyilima, MSc

CONTACT

+254702836210suzane.nyilima@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistantprofessor

Study Record Dates

First Submitted

December 18, 2025

First Posted

January 2, 2026

Study Start

December 23, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

January 2, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)KE(1)