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Tests treatment safety and results for Pregnancy
Official title Efficacy and Adverse Side Effects of Two Forms of Iron in Pregnancy
ClinicalTrials.gov ID: NCT06014983
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 42, women only. Healthy volunteers may be eligible.
You may be able to join 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 likely can't join if
- Having a pre-existing medical condition known to impact iron status (e.g., inherited hemoglobin disorder (i.e., sickle cell, hemochromatosis...
- Using medications known to interfere with iron metabolism or the gut pathogen equilibrium (e.g., chronic use of proton pump inhibitors...
- 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
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 19 years to 42 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.