Comparing two forms of iron supplementation during pregnancy
Efficacy and Adverse Side Effects of Two Forms of Iron in Prenatal Micronutrient Supplements (EASE-Iron): A Randomized Controlled Trial
This study is testing which of two types of iron supplements works better for pregnant people to improve their iron levels and overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 172 (estimated) |
| Ages | 19 Years to 42 Years |
| Sex | Female |
| Sponsor | University of British Columbia Academic / other |
| Locations | 2 sites (Vancouver, British Columbia and 1 other locations) |
| Trial ID | NCT06014983 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are generally healthy, low-risk pregnant individuals aged 19-42 years who are between 13-25 weeks gestation.
Not a fit: Patients with pre-existing medical conditions affecting iron status or those on medications that interfere with iron metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved iron supplementation practices that enhance maternal and fetal health during pregnancy.
How similar studies have performed: Other studies have explored iron supplementation in pregnancy, but this specific comparison of bioavailable forms is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vancouver, British Columbia and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.