Iron supplementation's effect on vaccine response in Kenyan women with anemia
Effects of Oral Iron Supplementation Before vs at Time of Vaccination on Immune Response in Iron Deficient Kenyan Women
This study tests if giving iron supplements to Kenyan women with anemia before or during vaccination can help them respond better to vaccines like those for COVID-19 and meningitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | Female |
| Sponsor | Swiss Federal Institute of Technology Academic / other |
| Locations | 1 site (Nairobi) |
| Trial ID | NCT06116669 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of oral iron supplementation on the immune response to vaccines in iron-deficient Kenyan women. It aims to determine whether administering iron before or at the time of vaccination enhances the effectiveness of vaccines against diseases like COVID-19 and meningitis. The trial will be conducted as a double-blind randomized controlled trial in southern Kenya, focusing on women aged 18-49 with moderate anemia. The study will assess both the impairment of vaccine response due to iron deficiency and the optimal timing for iron treatment.
Who should consider this trial
Good fit: Ideal candidates are iron-deficient women aged 18-49 living in southern Kenya with moderate anemia.
Not a fit: Patients with major chronic diseases, recent vaccinations, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve vaccine efficacy in iron-deficient populations, leading to better health outcomes.
How similar studies have performed: Previous studies have shown that intravenous iron can enhance vaccine responses, suggesting potential success for this oral iron approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Nairobi
- Jomo Kenyatta University Of Agriculture And Technology — Nairobi, Kenya (Recruiting)
Study contacts
- Study coordinator: Giulia Pironaci, MSc
- Email: giulia.pironaci@hest.ethz.ch
- Phone: +41 44 632 93 29
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.