Effects of Oral Iron Supplementation on Vaccine Response in Iron Deficient Kenyan Women

Launched by PROF SIMON KARANJA · Jun 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how oral iron supplements might help improve the response to vaccines in women from Kenya who have iron deficiency anemia (IDA). Iron deficiency anemia is a condition where the body lacks enough iron, leading to low levels of hemoglobin, which can affect how well vaccines work. The researchers want to find out if giving iron supplements before or at the same time as vaccinations can help improve their effectiveness. The trial will involve women aged 18 to 49 who are moderately anemic and iron deficient.

Participants in the study will be randomly assigned to one of three groups: one group will take iron supplements for eight weeks before vaccination, another group will take a placebo (a pill with no active ingredients) for the first four weeks and then iron supplements for the next four weeks, and the last group will take a placebo throughout the study. All groups will receive three vaccines on the same day, and the researchers will check how well the body responds to these vaccines a month later. Women who have certain health conditions or have received specific vaccines recently will not be eligible to participate. This study is important because it could help improve vaccine responses in women with anemia, ultimately benefitting public health.

Gender

FEMALE

Eligibility 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