Pregnancy Related Clinical Trial
— IRONMUMOfficial title:
Iron Supplementation and Immune Responses to Maternal Vaccination in Pregnant Women
Verified date | May 2024 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 150 |
Est. completion date | August 31, 2025 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Viable singleton pregnancy<28 weeks confirmed by ultrasound 2. 18 years and older 3. Willingness and ability to comply with the study protocol for the duration of the study 4. Can understand information about the study and provide consent Exclusion Criteria: 1. Any diphtheria-tetanus vaccine within the previous 2 years 2. History of allergic reaction to diphtheria-tetanus or COVID-19 vaccine 3. Haematocrit <21% or Haematocrit >50% 4. 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. 5. HIV-positive 6. Slide confirmed presence of malaria 7. Fever (defined at >37.5°C) 8. Symptoms of COVID (these women will be PCR tested as routine in clinic) 9. Known severe medical or obstetric complication e.g. valvular heart disease, placenta praevia 10. Known or clinical vitB12 deficiency as indicated by megaloblastic anaemia (pernicious anaemia or clinical symptoms) |
Country | Name | City | State |
---|---|---|---|
Thailand | Shoklo Malaria Research Unit (SMRU) | Mae Sot | Tak |
Lead Sponsor | Collaborator |
---|---|
University of Oxford |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | To assess if the amount of betel nut consumption relates to Haematocrit response | change from baseline and month 1,2 and 3 | ||
Primary | Antibody responses to maternal vaccine | Antibody responses to diphtheria-tetanus and SARS-CoV-2 immunisation, measured by ELISA. | 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 | Cellular Immune response post-immunisation measured by Mass Cytometry (plasma cells and circulating T-follicular helper cells). | 7-days after immunisation | ||
Secondary | Profile of the circulating immune system components over the course of pregnancy measured by CyTOF | change from before immunisation, 7-days and 28-days after immunization and until 2 months post-partum in mother and infant | ||
Secondary | Haematological, iron and inflammatory parameters including: Hb, MCV, haematocrit serum iron, ferritin, TSAT, hepcidin, CRP, G6PD, Hb typing. | change from before immunisation, 7-days and 28-days after immunization and at 2 months post-partum in mother and infant | ||
Secondary | Haematocrit from baseline if anaemic at baseline according to trimester of gestation | change from baseline and month 1,2 and 3, and delivery | ||
Secondary | 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] | Month 1,2 and 3 | |
Secondary | To monitor safety of iron supplements | Monitor adverse events in mother and neonate - gastrointestinal (e.g. constipation, diarrhea, infection) | change from baseline and month 1,2 and 3 |
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