Actively Recruiting
Efficacy and Adverse Side Effects of Two Forms of Iron in Pregnancy
Led by University of British Columbia · Updated on 2026-04-24
172
Participants Needed
2
Research Sites
142 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Adverse Side Effects of Two Forms of Iron in Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant individual with a single baby
- Between 19 and 42 years old
- Living in the greater Vancouver area and able to travel for study visits
- Between 13 and 25 weeks of pregnancy
- Willing and able to provide informed consent
You will not qualify if you...
- Having medical conditions that affect iron status, such as inherited hemoglobin disorders, malabsorptive disorders, inflammatory bowel disease, gastric bypass surgery, atrophic gastritis, advanced liver disease, or kidney dialysis
- Using medications that interfere with iron metabolism or gut bacteria, including chronic use of proton pump inhibitors, anti-inflammatory drugs, non-steroidal anti-inflammatory drugs, or antibiotics
- Personal history of neural tube defects or previous pregnancy affected by neural tube defects
- Receiving ongoing blood transfusions
- Currently smoking or having smoked within the past 3 months
- Pre-pregnancy body mass index of 30 kg/m² or higher
- Allergy to any ingredients in the study supplements
AI-Screening
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Trial Site Locations
Total: 2 locations
1
BC Women's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
Actively Recruiting
2
University of British Columbia, Food, Nutrition and Health Building
Vancouver, British Columbia, Canada, V6T 1Z4
Actively Recruiting
Research Team
C
Crystal Karakochuk, PhD
CONTACT
L
Lulu Pei, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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