Impact of oral iron on vaccine response in iron deficient women in Kenya
Effects of Oral Iron Supplementation Before vs. at Time of Vaccination on Immune Response in Iron Deficient Kenyan Women
This study is testing if giving oral iron to iron deficient women in Kenya can improve their response to vaccines like COVID-19 and others.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | Female |
| Sponsor | Jomo Kenyatta University of Agriculture and Technology Academic / other |
| Locations | 1 site (Msambweni) |
| Trial ID | NCT05919472 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of oral iron supplementation on vaccine response among iron deficient women of reproductive age in Kenya. It aims to determine if iron deficiency anemia (IDA) impairs vaccine efficacy and whether pre-treatment or simultaneous treatment with oral iron can enhance vaccine responses. The study will be conducted as a double-blind randomized controlled trial, focusing on the COVID-19 and MenACWY vaccines, as well as the Typhim Vi vaccine. The research is crucial given the high prevalence of IDA in Africa and its potential impact on public health.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-49 years with moderate anemia and iron deficiency living in the study area.
Not a fit: Patients with major chronic diseases, recent vaccinations, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve vaccine efficacy in iron deficient women, leading to better health outcomes.
How similar studies have performed: Previous studies have shown that intravenous iron can enhance vaccine responses in similar populations, suggesting potential for success with oral iron supplementation.
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 infectious disease (e.g., HIV infection); * Major chronic non-infectious 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 * Typhoid vaccine in the past * Pregnant (confirmed by rapid test during screening) or lactating. * Malaria (confirmed by rapid test) à study start will be postponed
Where this trial is running
Msambweni
- Msambweni County Referral Hospital — Msambweni, Kenya (Recruiting)
Study contacts
- Principal investigator: Simon Karanja, PhD — Jkuat
- Study coordinator: Giulia Pironaci, MSc
- Email: giulia.pironaci@rdm.ox.ac.uk
- 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.