Efficacy and Adverse Side Effects of Two Forms of Iron in Pregnancy

Launched by UNIVERSITY OF BRITISH COLUMBIA · Aug 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and side effects of two different forms of iron supplements during pregnancy to help prevent iron deficiency. The trial will involve 208 healthy pregnant individuals aged 19 to 42 living in the Vancouver area. Participants will be randomly assigned to receive either ferrous fumarate or ferrous bisglycinate, along with a prenatal multivitamin that does not contain iron. They will take these supplements daily until delivery, with an option to continue for about four weeks after giving birth for breastmilk testing. Researchers will check blood samples at the beginning and around 37 weeks of pregnancy to see how well each type of iron works for the body.

To participate, individuals must be pregnant with a single baby, between 19 to 42 years old, and in the 13 to 25 weeks of pregnancy range. They should also be willing to travel for study visits. However, those with certain medical conditions that affect iron levels or gut health, or who are taking specific medications, may not be eligible. Participants can expect to have their health monitored throughout the study, and the findings will help create better guidelines for iron supplementation in pregnant individuals and their babies.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Pregnant individual (singleton pregnancy)
• • 19-42 years of age
• • Living in the greater Vancouver area and willing to travel to the University of British Columbia or BC Women's Hospital for study visits
• • 13-25 weeks gestation
• • Willing to participate and able to provide informed consent
• Exclusion Criteria:
• • Having a pre-existing medical condition known to impact iron status (e.g., inherited hemoglobin disorder (i.e., sickle cell, hemochromatosis, thalassemia or other structural hemoglobin variant), malabsorptive disorders (i.e., chronic pancreatitis, cystic fibrosis, celiac disease) and inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis), gastric bypass surgery, atrophic gastritis, advanced liver disease, kidney dialysis)
• • Using medications known to interfere with iron metabolism or the gut pathogen equilibrium (e.g., chronic use of proton pump inhibitors, anti-inflammatory agents, non-steroidal anti-inflammatory drugs, antibiotics)
• • Having a personal neural tube defect (NTD) history or a previous NTD pregnancy
• • Receiving ongoing blood transfusions
• • Currently smoking or having smoked in the past 3 months
• • Pre-pregnancy body mass index (BMI) ≥30 kg/m\^2
• • Allergy to any study supplement ingredients