CompletedNot Applicable

Effects of Iron Supplementation on Pediatric Vaccine Response

Kenya, Switzerland288 participantsStarted 2021-02-07

Plain-language summary

ID/IDA affects many young children in Africa. Vaccines provide tremendous benefits in LMIC; however, they currently fail to reach their full potential. We need to better understand the causes of vaccine failure, in order to develop new strategies to improve vaccine immunogenicity. This study will contribute to children's health by: (1) providing updated guidelines to better define the prevalence of ID/IDA in early infancy, and its safe and effective control using iron; and (2) providing a new approach to improve response to pediatric vaccines in LMIC, by ensuring adequate iron status at time of vaccination.

Who can participate

Age range39 Days – 45 Days

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Mother at least ≥15 years of age. * 6 weeks (+/- 3 days) of age * Iron deficient (erythrocyte zinc protoporphyrin (ZnPP) \>61 μmol/mol heme) * With or without anemia, but not severely anemic (Hb \>70 g/L) * No malaria * No medical condition that precludes study involvement * Mother HIV negative * Vaginal delivery * No iron supplementation prior to study enrolment * Not wasted (length for height z score of ≥-2) * Not underweight (weight for age z score ≥-2) * From the hospital record, term or late preterm delivery (≥34 weeks) * Full-time breastfed at least until the screening * No vaccines beyond the birth dose of OPV and BCG prior to enrolment

What they're measuring

Pertussis antibody profile

Timeframe: from 6 to 24 weeks

Diphtheria antibody profile

Timeframe: from 6 to 24 weeks

Trial details

NCT IDNCT04744818

SponsorJessica Rigutto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-03

View on ClinicalTrials.gov More Iron-deficiency trials