Status:
COMPLETED
Effects of Iron Supplementation on Pediatric Vaccine Response
Lead Sponsor:
Jessica Rigutto
Collaborating Sponsors:
Jomo Kenyatta University of Agriculture and Technology Kenya
Karolinka Institute Sweden
Conditions:
Iron-deficiency
Iron Deficiency Anemia
Eligibility:
All Genders
39-45 years
Phase:
NA
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 vacci...
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 recom...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2023
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT04744818
Start Date
February 7 2021
End Date
October 16 2023
Last Update
January 24 2024
Active Locations (2)
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1
Msambweni County Referral Hospital
Msambweni, Kwale County, Kenya
2
Human Nutrition Laboratory ETH Zurich
Zurich, Switzerland, 8092