Pregnancy RelatedIRONMUMNCT05385042
Iron and Immune Response to Vaccine (IRONMUM)
A study testing Sangobion and Thiamine Hydrochloride and Sangobion, Thiamine hydrochloride and Vitamin B12 in people with Pregnancy Related, run by University of Oxford at 1 site in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Sangobion and Thiamine Hydrochloride and Sangobion, Thiamine hydrochloride and Vitamin B12
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteThailand
- Study dates
- 18 Jun 2022to 22 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to 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
Who cannot join
- Any diphtheria-tetanus vaccine within the previous 2 years
- History of allergic reaction to diphtheria-tetanus or COVID-19 vaccine
- Haematocrit <21% or Haematocrit >50%
- Known severe haemoglobinopathy (HbE/beta-thalassaemia syndrome, beta-thalassaemia major or HbH syndrome)* or G6PD deficiency
- Iron supplementation is safe in pregnant women with haemoglobin E, alpha-thalassemia 1, or beta-thalassemia carriers.
- HIV-positive
Show all 11Show fewer
- Slide confirmed presence of malaria
- Fever (defined at >37.5°C)
- Symptoms of COVID (these women will be PCR tested as routine in clinic)
- Known severe medical or obstetric complication e.g. valvular heart disease, placenta praevia
- Known or clinical vitB12 deficiency as indicated by megaloblastic anaemia (pernicious anaemia or clinical symptoms)
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Shoklo Malaria Research Unit (SMRU)
Mae Sot, Changwat Tak, 63110
About this study
Official title: Iron Supplementation and Immune Responses to Maternal Vaccination in Pregnant Women
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. Low iron has been recognized as a cause of poor immune response because the group of cells that need to increase to make the immune response need iron to function. Vaccination is an important part of care during pregnancy because components of the immune response can cross the placenta and protect the young infant. More recently COVID-19 vaccination has also been recommended for pregnant women due to their higher risk of dying from this infection. Deeper investigation of whether low iron results in poor immune response is needed because the vaccines may not be providing as much protection as needed. The World Health Organization also recommends nutritional iron supplements in pregnancy and whether these improve immune response to vaccines is also not known. This study aims to test the body's immune response to recommended vaccines in pregnant women (tetanus and diphtheria (combination) and COVID-19 vaccine (if indicated)) who are anaemic and receiving iron supplements and compare their response to women who are not anaemic, who only receive a preventive, lower dose of supplement.
Read the detailed description
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. Consenting pregnant women will be enrolled at first antenatal clinic [7] visit and receive tetanus and diphtheria immunisation after confirmation of vaccination history, and SARS-CoV-2 immunisation (first dose if indicated). All women will be classified as non-anaemic or anaemic based on haematocrit (Haematocrit<33% in first trimester (defined <14 weeks) and Haematocrit <30% in 2nd trimester (defined 14 to <28 weeks)). Women will be assigned to groups and receive prophylactic (non-anaemic) or treatment (anaemic) doses of nutritional supplements, respectively, as per routine practice. 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. Mother and infant blood samples will be taken at the 2 months post-partum visit when the newborn attends for routine vaccinations of the expanded program of immunisation. Immunological and haematological responses will be measured by venous blood sampling and finger-prick sampling (routine at the clinics) at study visits; as will adverse events in relation to nutritional supplements by monthly questions using a checklist of common reactions to oral iron. The Adherence Starts with Knowledge (ASK-12) instrument has been modified and used in this population and will be compared to the Haematocrit levels, the pill count and adverse events, as a measure of adherence.
IRONMUM study is funded by Procter and Gamble. The grant reference number is Thailand-UK-IRONMUM-2021-01.
- Conditions
- Pregnancy Related
- Being tested
- Sangobion and Thiamine Hydrochloride, Sangobion, Thiamine hydrochloride and Vitamin B12
- Keywords
- Iron supplementation, Immune responses, Maternal vaccination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sangobion and Thiamine HydrochlorideDietary supplement
Prophylactic dietary supplements: 1 capsule of Sangobion + separate Thiamine Hydrochloride tablet 100mg per day for 12 weeks.
Then non-anaemic pregnant women will continue with prophylactic nutritional supplements until delivery.
Sangobion, Thiamine hydrochloride and Vitamin B12Dietary supplement
Treatment dietary supplements: 3 capsules of Sangobion + separate Thiamine Hydrochloride tablet 100mg, Vit B12 100mcg per day for 12 weeks.
If experience a therapeutic increase of 3% Haematocrit within 28 days (responders), they will continue with prophylactic nutritional supplements until delivery.
If no affect in Haematocrit level within 28 days (non-responders; defined by trimester of diagnosis), they will be investigated for their serum ferritin and if this is low (<15ng/mL) intravenous (iv) iron supplement (Venofer®) will be provided. The dose will be calculated for the individual concerned (required iron dose (mg) = (2.4 x (target Hb of 11g/dL (Ht 33%) x pre-pregnancy weight (kg) +1000mg for replenishment of stores). Doses will be administered by slow iv infusion 200 mg per dose (maximum of 3 doses per week).
Following treatment they will continue with prophylactic nutritional supplements.
| Study group | Role | What they receive |
|---|---|---|
| Non-anaemic pregnant women | Other | 50 pregnant women who have normal haematocrit (not anaemic) at 12 weeks. Receives: Dietary Supplement: Sangobion and Thiamine Hydrochloride |
| Anaemic pregnant women | Other | 100 pregnant women who have haematocrit below 33% (equates to Hb 11g/dL) in first trimester (<14 weeks gestation) and below 30% (equates to Hb 10g/dL). Receives: Dietary Supplement: Sangobion, Thiamine hydrochloride and Vitamin B12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody responses to maternal vaccine
Antibody responses to diphtheria-tetanus and SARS-CoV-2 immunisation, measured by ELISA.
Measured: change from baseline before immunisation and at 7-days and 28-days after immunisation, and at 2 months post-partum in mother and infant.
Secondary outcomes (6)
Cellular Immune response post-immunisation measured by Mass Cytometry (plasma cells and circulating T-follicular helper cells).
Measured: 7-days after immunisation
Profile of the circulating immune system components over the course of pregnancy measured by CyTOF
Measured: change from before immunisation, 7-days and 28-days after immunization and until 2 months post-partum in mother and infant
Haematological, iron and inflammatory parameters including: Hb, MCV, haematocrit serum iron, ferritin, TSAT, hepcidin, CRP, G6PD, Hb typing.
Measured: change from before immunisation, 7-days and 28-days after immunization and at 2 months post-partum in mother and infant
Haematocrit from baseline if anaemic at baseline according to trimester of gestation
Measured: change from baseline and month 1,2 and 3, and delivery
Modified Adherence Starts with Knowledge (ASK-12) questionnaire including pill count.
ASK-12 scores can range from 12-60, with higher scores representing greater barriers to adherence]
Measured: Month 1,2 and 3
To monitor safety of iron supplements
Monitor adverse events in mother and neonate - gastrointestinal (e.g. constipation, diarrhea, infection)
Measured: change from baseline and month 1,2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start18 Jun 2022
- Primary completion22 Jul 2025
- Study completion22 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hal Drakesmith, Dr., Principal investigator, MRC Human Immunology Unit, John Radcliffe Hospital, University of Oxford, OX3 9DS UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385042
- Sponsor's protocol ID
- HCR22001
- Acronym
- IRONMUM
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2022
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All personal details of participants will be de-identified. These data including laboratory investigation results will be stored and may be shared to other researchers to apply in their research in accordance with the MORU data sharing policy.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Supplementation and Immune Responses to Maternal Vaccination in Pregnant Women
- ClinicalTrials.gov ID
- NCT05385042
- Acronym / sponsor ID
- IRONMUM / HCR22001
- Conditions
- Pregnancy Related
- Keywords
- Iron supplementation, Immune responses, Maternal vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 18 Jun 2022 (actual)
- Primary completion
- 22 Jul 2025 (actual)
- Study completion
- 22 Jul 2025 (actual)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Low iron has been recognized as a cause of poor immune response because the group of cells that need to increase to make the immune response need iron to function. Vaccination is an important part of care during pregnancy because components of the immune response can cross the placenta and protect the young infant. More recently COVID-19 vaccination has also been recommended for pregnant women due to their higher risk of dying from this infection. Deeper investigation of whether low iron results in poor immune response is needed because the vaccines may not be providing as much protection as needed. The World Health Organization also recommends nutritional iron supplements in pregnancy and whether these improve immune response to vaccines is also not known. This study aims to test the body's immune response to recommended vaccines in pregnant women (tetanus and diphtheria (combination) and COVID-19 vaccine (if indicated)) who are anaemic and receiving iron supplements and compare their response to women who are not anaemic, who only receive a preventive, lower dose of supplement.
Detailed description
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. Consenting pregnant women will be enrolled at first antenatal clinic [7] visit and receive tetanus and diphtheria immunisation after confirmation of vaccination history, and SARS-CoV-2 immunisation (first dose if indicated). All women will be classified as non-anaemic or anaemic based on haematocrit (Haematocrit<33% in first trimester (defined <14 weeks) and Haematocrit <30% in 2nd trimester (defined 14 to <28 weeks)). Women will be assigned to groups and receive prophylactic (non-anaemic) or treatment (anaemic) doses of nutritional supplements, respectively, as per routine practice. 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. Mother and infant blood samples will be taken at the 2 months post-partum visit when the newborn attends for routine vaccinations of the expanded program of immunisation. Immunological and haematological responses will be measured by venous blood sampling and finger-prick sampling (routine at the clinics) at study visits; as will adverse events in relation to nutritional supplements by monthly questions using a checklist of common reactions to oral iron. The Adherence Starts with Knowledge (ASK-12) instrument has been modified and used in this population and will be compared to the Haematocrit levels, the pill count and adverse events, as a measure of adherence.
IRONMUM study is funded by Procter and Gamble. The grant reference number is Thailand-UK-IRONMUM-2021-01.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-anaemic pregnant women | Other | Dietary Supplement: Sangobion and Thiamine Hydrochloride50 pregnant women who have normal haematocrit (not anaemic) at 12 weeks. |
| Anaemic pregnant women | Other | Dietary Supplement: Sangobion, Thiamine hydrochloride and Vitamin B12100 pregnant women who have haematocrit below 33% (equates to Hb 11g/dL) in first trimester (<14 weeks gestation) and below 30% (equates to Hb 10g/dL). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- Any diphtheria-tetanus vaccine within the previous 2 years
- History of allergic reaction to diphtheria-tetanus or COVID-19 vaccine
- Haematocrit <21% or Haematocrit >50%
- Known severe haemoglobinopathy (HbE/beta-thalassaemia syndrome, beta-thalassaemia major or HbH syndrome)* or G6PD deficiency
- HIV-positive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sangobion and Thiamine HydrochlorideProphylactic dietary supplements: 1 capsule of Sangobion + separate Thiamine Hydrochloride tablet 100mg per day for 12 weeks. Then non-anaemic pregnant women will continue with prophylactic nutritional supplements until delivery. | Dietary supplement | Non-anaemic pregnant women |
| Sangobion, Thiamine hydrochloride and Vitamin B12Treatment dietary supplements: 3 capsules of Sangobion + separate Thiamine Hydrochloride tablet 100mg, Vit B12 100mcg per day for 12 weeks. If experience a therapeutic increase of 3% Haematocrit within 28 days (responders), they will continue with prophylactic nutritional supplements until delivery. If no affect in Haematocrit level within 28 days (non-responders; defined by trimester of diagnosis), they will be investigated for their serum ferritin and if this is low (<15ng/mL) intravenous (iv) iron supplement (Venofer®) will be provided. The dose will be calculated for the individual concerned (required iron dose (mg) = (2.4 x (target Hb of 11g/dL (Ht 33%) x pre-pregnancy weight (kg) +1000mg for replenishment of stores). Doses will be administered by slow iv infusion 200 mg per dose (maximum of 3 doses per week). Following treatment they will continue with prophylactic nutritional supplements. | Dietary supplement | Anaemic pregnant women |
Primary outcome
Antibody responses to maternal vaccine
Time frame: change from baseline before immunisation and at 7-days and 28-days after immunisation, and at 2 months post-partum in mother and infant.
Antibody responses to diphtheria-tetanus and SARS-CoV-2 immunisation, measured by ELISA.
6 secondary outcomes
Cellular Immune response post-immunisation measured by Mass Cytometry (plasma cells and circulating T-follicular helper cells).
Time frame: 7-days after immunisation
Profile of the circulating immune system components over the course of pregnancy measured by CyTOF
Time frame: change from before immunisation, 7-days and 28-days after immunization and until 2 months post-partum in mother and infant
Haematological, iron and inflammatory parameters including: Hb, MCV, haematocrit serum iron, ferritin, TSAT, hepcidin, CRP, G6PD, Hb typing.
Time frame: change from before immunisation, 7-days and 28-days after immunization and at 2 months post-partum in mother and infant
Haematocrit from baseline if anaemic at baseline according to trimester of gestation
Time frame: change from baseline and month 1,2 and 3, and delivery
Modified Adherence Starts with Knowledge (ASK-12) questionnaire including pill count.
Time frame: Month 1,2 and 3
To monitor safety of iron supplements
Time frame: change from baseline and month 1,2 and 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: Yes. All personal details of participants will be de-identified. These data including laboratory investigation results will be stored and may be shared to other researchers to apply in their research in accordance with the MORU data sharing policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hal Drakesmith, Dr. principal investigator
MRC Human Immunology Unit, John Radcliffe Hospital, University of Oxford, OX3 9DS UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sangobion and Thiamine Hydrochloride and Sangobion, Thiamine hydrochloride and Vitamin B12 in people with Pregnancy Related, run by University of Oxford at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody responses to maternal vaccine (time frame: change from baseline before immunisation and at 7-days and 28-days after immunisation, and at 2 months post-partum in mother and infant.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.