Status:
RECRUITING
Efficacy and Adverse Side Effects of Two Forms of Iron in Pregnancy
Lead Sponsor:
University of British Columbia
Conditions:
Pregnancy
Iron Deficiency
Eligibility:
FEMALE
19-42 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
To address our primary aim of determining the optimal form of iron in prenatal supplements, we seek to answer the following research questions: 1. Does providing a more bioavailable form of iron (24 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT06014983
Start Date
April 12 2024
End Date
January 1 2026
Last Update
January 17 2025
Active Locations (2)
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1
BC Women's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
2
University of British Columbia, Food, Nutrition and Health Building
Vancouver, British Columbia, Canada, V6T 1Z4