Clinical trial · Interventional
Effects of Iron Supplementation on Pediatric Vaccine Response
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Iron-deficiency | — | UNRESOLVED | — |
| Iron Deficiency Anemia | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Vaccination | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Iron syrup | Dietary Supplement | — | UNRESOLVED |
| Multivitamin syrup | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Immediate iron treatment
- description
- Iron and multivitamin syrup
- interventionNames
- Dietary Supplement: Iron syrup
- Dietary Supplement: Multivitamin syrup
- type
- PLACEBO_COMPARATOR
- label
- Delayed iron treatment
- description
- Multivitamin syrup
- interventionNames
- Dietary Supplement: Multivitamin syrup
Primary outcomes (2)
- measure
- Pertussis antibody profile
- timeFrame
- from 6 to 24 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 39 Days
- Maximum age
- 45 Days
Show eligibility criteria text
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
References
Publications (0)
Data not yet available