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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age19-42
SponsorUniversity of British Columbia

About this trial

This two-arm, double-blind randomized clinical trial will recruit 172 generally healthy, low-risk pregnant individuals aged 19-42 years living in Vancouver, Canada. Participants will be randomized to receive one of two forms of iron (ferrous fumarate or ferrous bisglycinate) in addition to a prenatal multivitamin (without iron) daily during their pregnancy until delivery, with optional continuation until \~4 weeks postpartum for breastmilk sample collection. Blood samples will be taken at baseline (13-25 weeks gestation) and follow-up (35-37 weeks gestation) to assess how different forms of iron impact body iron stores. Stool samples will be obtained within 1 week of both baseline and follow-up visits to assess changes in gut microbiome composition. This research will inform more specific guidelines for optimal iron supplementation practices for the prevention and treatment of iron deficiency for both mother and baby.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Ferrous fumarate
  • Ferrous bisglycinate

Treatment groups

172 Participants
are divided into 2 treatment groups

Sponsors and collaborators