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Efficacy and Adverse Side Effects of Two Forms of Iron in Pregnancy
Sponsor: University of British Columbia
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 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.
Official title: Efficacy and Adverse Side Effects of Two Forms of Iron in Prenatal Micronutrient Supplements (EASE-Iron): A Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
19 Years - 42 Years
Study Type
INTERVENTIONAL
Enrollment
172
Start Date
2024-04-12
Completion Date
2026-01
Last Updated
2025-01-17
Healthy Volunteers
Yes
Conditions
Interventions
Ferrous fumarate
Participants will supplement with 24 mg elemental iron in the form of ferrous fumarate daily for a minimum of 12 weeks.
Ferrous bisglycinate
Participants will supplement with 24 mg elemental iron in the form of ferrous bisglycinate daily for a minimum of 12 weeks.
Locations (2)
BC Women's Hospital
Vancouver, British Columbia, Canada
University of British Columbia, Food, Nutrition and Health Building
Vancouver, British Columbia, Canada