RecruitingNot ApplicableNCT06014983

Efficacy and Adverse Side Effects of Two Forms of Iron in Pregnancy

Efficacy and Adverse Side Effects of Two Forms of Iron in Prenatal Micronutrient Supplements (EASE-Iron): A Randomized Controlled Trial


Sponsor

University of British Columbia

Enrollment

172 participants

Start Date

Apr 12, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 19 YearsMax Age: 42 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Ferrous bisglycinate and Ferrous fumarate for people with iron-deficiency and pregnancy. The study is currently recruiting participants at 2 locations. People eligible for this study include women aged 19 Years to 42 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTFerrous fumarate

Participants will supplement with 24 mg elemental iron in the form of ferrous fumarate daily for a minimum of 12 weeks.

DIETARY_SUPPLEMENTFerrous 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

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NCT06014983


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