Comparing two forms of iron supplementation during pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the efficacy and side effects of two different forms of iron supplementation, ferrous fumarate and ferrous bisglycinate, in pregnant individuals. A total of 172 healthy, low-risk pregnant participants aged 19-42 years will be recruited in Vancouver, Canada, and randomized to receive one of the two iron supplements along with a prenatal multivitamin. Blood and stool samples will be collected at baseline and follow-up to assess iron levels and gut microbiome changes. The findings will help establish better guidelines for iron supplementation in pregnancy to prevent and treat iron deficiency.

Why it matters

Who can join: the full rules

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

Where it's running

• BC Women's Hospital
  Vancouver, British Columbia, Canada Recruiting
• University of British Columbia, Food, Nutrition and Health Building
  Vancouver, British Columbia, Canada Recruiting

Study contacts

• Principal investigator: Crystal Karakochuk, PhD — University of British Columbia
• Study coordinator: Crystal Karakochuk, PhD
• Email: crystal.karakochuk@ubc.ca
• Phone: 604-822-0421

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.