The Effects of Iron Treatment on Malaria and Measles Vaccine Response in Kenyan Infants With Iron Deficiency
NCT ID: NCT06816524
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
324 participants
INTERVENTIONAL
2026-01-05
2028-04-30
Brief Summary
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In this double-blind randomized controlled trial, we aim to assess: (1) whether ID impairs R21/Matrix-M and measles (MR) vaccine response, (2) whether iron treatment at time of vaccination improves vaccine response.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Iron treatment group
daily multivitamin + daily iron syrup from age 6 to 10 months
Iron syrup
Iron syrup administered daily from 6 to 10 months of age.
Multivitamin syrup
Multivitamin syrup administered daily from 6 to 10 months of age.
R21-Matrix/M Vaccine (malaria vaccine)
R21-Matrix/M vaccine administered in 3 doses at 7, 8 and 9 months of age.
Measles-Rubella vaccine
Measles-Rubella vaccine administered at 9 months of age.
Control group
daily multivitamin syrup from age 6 to 10 months
Multivitamin syrup
Multivitamin syrup administered daily from 6 to 10 months of age.
R21-Matrix/M Vaccine (malaria vaccine)
R21-Matrix/M vaccine administered in 3 doses at 7, 8 and 9 months of age.
Measles-Rubella vaccine
Measles-Rubella vaccine administered at 9 months of age.
Interventions
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Iron syrup
Iron syrup administered daily from 6 to 10 months of age.
Multivitamin syrup
Multivitamin syrup administered daily from 6 to 10 months of age.
R21-Matrix/M Vaccine (malaria vaccine)
R21-Matrix/M vaccine administered in 3 doses at 7, 8 and 9 months of age.
Measles-Rubella vaccine
Measles-Rubella vaccine administered at 9 months of age.
Eligibility Criteria
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Inclusion Criteria
* Male or Female, 6 months (+/- 2 weeks) of age
* Mother at least ≥15 years of age
* Iron deficient (erythrocyte zinc protoporphyrin (ZnPP) \>61 μmol/mol heme)
* With or without anemia (anemia defined by Hb \<110 g/L)
Exclusion Criteria
* Malaria vaccination prior to enrollment
* Medical condition that precludes study involvement
* Iron supplementation 2 weeks before enrollment
* Acute or chronic infection (e.g. HIV)
* Wasted (length for height z score of ≥-2) or underweight (weight for age z score ≥-2).
6 Months
6 Months
ALL
No
Sponsors
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Jomo Kenyatta University of Agriculture and Technology
OTHER
University of Oxford - Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences
UNKNOWN
Faculty of Medical Sciences, Radboud University of Medical Center
UNKNOWN
National Institute for Public Health and the Environment (RIVM)
OTHER_GOV
Nicole Stoffel
OTHER
Responsible Party
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Nicole Stoffel
Prof.
Principal Investigators
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Nicole Stoffel, PhD
Role: PRINCIPAL_INVESTIGATOR
ETH Zurich
Central Contacts
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Other Identifiers
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MEMA
Identifier Type: -
Identifier Source: org_study_id