Iron Supplements for Iron Deficiency in Pregnancy (EASE-Iron Trial)

N/A

Recruiting

Led By Crystal Karakochuk, PhD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pregnant individual (singleton pregnancy) 19-42 years of age

Be between 18 and 65 years old

Must not have

Receiving ongoing blood transfusions

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up placenta collected at time of delivery

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate how different forms of iron affect pregnant people and their babies. Blood & gut samples will be taken to assess impact. Results will help inform optimal iron supplementation.

Who is the study for?

This trial is for healthy pregnant individuals aged 19-42 in Vancouver, expecting one baby and planning to deliver at BC Women's Hospital. They should be 13-25 weeks into their pregnancy and able to visit the University of British Columbia. Exclusions include a BMI ≥30, smoking recently, certain pre-existing conditions affecting iron levels, or use of specific medications.

What is being tested?

The study tests two types of iron supplements: Ferrous fumarate and Ferrous bisglycinate taken with prenatal vitamins during pregnancy until delivery. The goal is to compare how each supplement affects body iron stores and gut bacteria presence by analyzing blood samples and rectal swabs from start till around week 37.

What are the potential side effects?

Potential side effects may include gastrointestinal discomfort such as constipation or diarrhea, nausea, abdominal pain due to the iron supplements. These are common reactions when taking oral iron but can vary between individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am pregnant, between 19 and 42 years old, and expecting one baby.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently receiving blood transfusions.

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I am not on medications that affect iron levels or gut bacteria balance.

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My BMI was 30 or higher before I got pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ blood sample collected at baseline (13-25 weeks gestation) and at endline (37 weeks gestation)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~blood sample collected at baseline (13-25 weeks gestation) and at endline (37 weeks gestation)

This trial's timeline: 3 weeks for screening, Varies for treatment, and blood sample collected at baseline (13-25 weeks gestation) and at endline (37 weeks gestation) for reporting.