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

Recruiting now · Not applicable

Conditions studied: Pregnancy, Iron Deficiency

In brief

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.

Key facts

Study ID

NCT06014983

Run by

University of British Columbia

People needed

172

Starts

2024-04-12

Expected to finish

2027-01-01

Last updated by the study team

2026-04-24

Who can join

Age: 19 and older, up to 42. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• BC Women's Hospital — Vancouver, British Columbia, Canada (enrolling)
• University of British Columbia, Food, Nutrition and Health Building — Vancouver, British Columbia, Canada (enrolling)

Full record on ClinicalTrials.gov

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