Status:
RECRUITING
Effects of Oral Iron Supplementation Before vs at Time of Vaccination on Immune Response in Iron Deficient Kenyan Women
Lead Sponsor:
Swiss Federal Institute of Technology
Collaborating Sponsors:
Jomo Kenyatta University of Agriculture and Technology
University of Oxford
Conditions:
Iron Deficiency Anemia
Eligibility:
FEMALE
18-49 years
Phase:
NA
Brief Summary
Iron deficiency (ID) anemia (IDA) is a global public health problem, with the highest prevalence in Africa. Vaccines often underperform in low- and middle-income countries (LMIC), and undernutrition, ...
Eligibility Criteria
Inclusion
- Willing and able to give informed consent for participation in the trial
- Female aged 18-49 years
- Moderate anemia (Hb \<110 g/L, but not severely anemic with Hb \<80 g/L)
- Iron deficient (ZnPP \>40 mmol/mol haem)
- Anticipated residence in the study area for the study duration
Exclusion
- Major chronic infecious disease (e.g., HIV infection);
- Major chronic non-infecious disease (e.g., Type 2 diabetes, cancer);
- Chronic medications;
- Use of iron-containing mineral and vitamin supplementation 2 weeks prior to study start;
- COVID-19 vaccine or confirmed COVID-19 infection within the past 2 years
- MenACWY vaccine in the past
- Typhim Vi vaccine in the past
- Pregnant (confirmed by rapid test during screening)
- Malaria (confirmed by rapid test) à study start will be postponed
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06116669
Start Date
November 1 2023
End Date
December 31 2024
Last Update
January 24 2024
Active Locations (1)
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1
Jomo Kenyatta University Of Agriculture And Technology
Nairobi, Kenya, 00200