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

NCT06014983 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2026-04-24

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Ferrous fumarate

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

DIETARY_SUPPLEMENT

Ferrous bisglycinate

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

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Crystal Karakochuk, PhD · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-12
Primary Completion
2026-12-31
Completion
2027-01-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06014983 on ClinicalTrials.gov