Effects of Iron Supplementation on Pediatric Vaccine Response
- Conditions
- VaccinationPediatric ALLIron-deficiencyIron Deficiency Anemia
- Interventions
- Dietary Supplement: Iron syrupDietary Supplement: Multivitamin syrup
- Registration Number
- NCT04744818
- Lead Sponsor
- Jessica Rigutto
- Brief 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.
- Detailed Description
Two major pediatric public health goals in LMIC are increasing immunization effectiveness and reducing ID/IDA in children. ID/IDA affects many young children in Africa. Current guidelines do not recommend routine testing of hemoglobin in early infancy, as it is generally believed that most infants are born with adequate iron stores to last 6 months. However, many African infants are born with low iron stores and ID/IDA may develop earlier than generally appreciated, within 2-3 months after birth. 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. Despite lower efficacy in LMIC, these vaccines provide a major benefit because the disease burden is so high; however, if approaches can be found to improve immunogenicity, these vaccines would be even more powerful.
For this study, 6 weeks old infants will be randomly assigned to two study groups. Group 1 will receive iron at time of pediatric vaccinations from age 6-24 weeks. Group 2 will receive no iron at time of pediatric vaccinations. All infants will receive a multivitamin syrup from age 6-24 weeks. All infants remaining ID/IDA at age 24 weeks will receive iron. Infants will be followed-up until age 52 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 288
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Immediate iron treatment Multivitamin syrup Iron and multivitamin syrup Delayed iron treatment Multivitamin syrup Multivitamin syrup Immediate iron treatment Iron syrup Iron and multivitamin syrup
- Primary Outcome Measures
Name Time Method Pertussis antibody profile from 6 to 24 weeks Diphtheria antibody profile from 6 to 24 weeks
- Secondary Outcome Measures
Name Time Method Calprotectin 24 weeks of age Gut inflammation
Proteomics 52 weeks of age Proteins involved in immune response
antiviral immunoglobulin G response 24 weeks of age Immunoassay
Hemoglobin 52 weeks of age Alpha-glycoprotein 52 weeks of age Haemophilus influenzae b antibody profile from 6 to 24 weeks Rotavirus antibody profile from 6 to 24 weeks Anti-vaccine antibody titers 52 weeks of age Anti-vaccine seroconversion 52 weeks of age Anti-vaccine antibody avidity index 52 weeks of age percentage of antibodies that remain bound to beads
infant antiviral immunoglobulin G response 52 weeks of age Immunoassay
C-reactive protein 52 weeks of age Tetanus antibody profile from 6 to 24 weeks immune cell populations 52 weeks of age number and type of immune cells
Plasma ferritin 52 weeks of age Polio antibody profile from 6 to 24 weeks Transcriptomics 24 weeks of age Genes involved in immune response
Intestinal fatty acid binding protein 24 weeks of age Gut inflammation
Plasma iron 52 weeks of age soluble transferrin receptor 52 weeks of age Pneumococcus antibody profile from 6 to 24 weeks
Trial Locations
- Locations (2)
Human Nutrition Laboratory ETH Zurich
🇨🇭Zürich, Switzerland
Msambweni County Referral Hospital
🇰🇪Msambweni, Kwale, Kenya