Actively Recruiting

Phase Not Applicable
Age: 19Years - 42Years
FEMALE
Healthy Volunteers
NCT06014983

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

Led by University of British Columbia · Updated on 2026-04-24

172

Participants Needed

2

Research Sites

142 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 19Years - 42Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant individual with a single baby
  • Between 19 and 42 years old
  • Living in the greater Vancouver area and able to travel for study visits
  • Between 13 and 25 weeks of pregnancy
  • Willing and able to provide informed consent
Not Eligible

You will not qualify if you...

  • Having medical conditions that affect iron status, such as inherited hemoglobin disorders, malabsorptive disorders, inflammatory bowel disease, gastric bypass surgery, atrophic gastritis, advanced liver disease, or kidney dialysis
  • Using medications that interfere with iron metabolism or gut bacteria, including chronic use of proton pump inhibitors, anti-inflammatory drugs, non-steroidal anti-inflammatory drugs, or antibiotics
  • Personal history of neural tube defects or previous pregnancy affected by neural tube defects
  • Receiving ongoing blood transfusions
  • Currently smoking or having smoked within the past 3 months
  • Pre-pregnancy body mass index of 30 kg/m² or higher
  • Allergy to any ingredients in the study supplements

AI-Screening

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Trial Site Locations

Total: 2 locations

1

BC Women's Hospital

Vancouver, British Columbia, Canada, V6H 3N1

Actively Recruiting

2

University of British Columbia, Food, Nutrition and Health Building

Vancouver, British Columbia, Canada, V6T 1Z4

Actively Recruiting

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Research Team

C

Crystal Karakochuk, PhD

CONTACT

L

Lulu Pei, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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