Iron and Immune Response to Vaccine (IRONMUM)

What Was Tested

In this not phased trial, researchers set out to test Cyanocobalamin (Vitamin B12).

Iron deficiency causes anaemia and is common in pregnant women especially for those living in tropical regions where a high burden of infection and poor nutrition can compromise health.

Vaccination is an important part of care during pregnancy because components of the immune response can cross the placenta and protect the young infant.

It had two arms (groups): Non-anaemic pregnant women (other) and Anaemic pregnant women (other).

50 pregnant women who have normal haematocrit (not anaemic) at 12 weeks.

The registry classes the interventions as dietary supplement.

More on the Plan

This is a prospective interventional open label cohort study with an exploratory framework.

After assessment of gestation by routine ultrasound, women will be invited to participate if they have a viable, singleton pregnancy with a gestation \< 28 weeks.

These supplements will be provided daily for 3 months (12 weeks) and women will be followed up at day 7, 1 month (day 28), 2 and 3 months.

There after they will follow routine antenatal care until birth when a cord blood sample will be taken.

Who Took Part

The registry lists 171 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Viable singleton pregnancy\<28 weeks confirmed by ultrasound. 18 years and older. Willingness and ability to comply with the study protocol for the duration of the study. Can understand information about the study and provide consent.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: any diphtheria-tetanus vaccine within the previous 2 years; history of allergic reaction to diphtheria-tetanus or covid-19 vaccine; known severe haemoglobinopathy (hbe/beta-thalassaemia syndrome, beta-thalassaemia major or hbh syndrome)\* or g6pd deficiency.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

The Cyanocobalamin (Vitamin B12) group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Cyanocobalamin (Vitamin B12) study: the participants and staff both knew the treatment.

It started in 2022-06-18 with completion listed for 2025-07-22.

It ran at 1 site in Thailand.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Antibody responses to maternal vaccine.

It also tracked 6 secondary outcomes, for example Cellular Immune response post-immunisation measured by Mass Cytometry (plasma cells and circulating T-follicular helper cells), Profile of the circulating immune system components over the course of pregnancy measured by CyTOF, Haematocrit from baseline if anaemic at baseline according to trimester of gestation, Modified Adherence Starts with Knowledge (ASK-12) questionnaire including pill count and To monitor safety of iron supplements.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Cyanocobalamin (Vitamin B12) in 171 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.