Recruiting

Ferrous Fumarate & Ferrous Bisglycinate

Sponsor:

University of British Columbia

Code:

NCT06014983

Conditions

Pregnancy

Iron Deficiency

Eligibility Criteria

Sex: Female

Age: 19 - 42

Healthy Volunteers: Accepted

Interventions

Ferrous fumarate

Ferrous bisglycinate

Study Details

Brief 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

Pregnancy

Iron Deficiency

Study ID

NCT06014983

Start date

Apr 12, 2024

Status verified date

Apr, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 19 - 42

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Pregnant individual (singleton pregnancy)
  • 19-42 years of age
  • Living in the greater Vancouver area and willing to travel to the University of British Columbia or BC Women's Hospital for study visits
  • 13-25 weeks gestation
  • Willing to participate and able to provide informed consent

Exclusion Criteria:

  • Having a pre-existing medical condition known to impact iron status (e.g., inherited hemoglobin disorder (i.e., sickle cell, hemochromatosis, thalassemia or other structural hemoglobin variant), malabsorptive disorders (i.e., chronic pancreatitis, cystic fibrosis, celiac disease) and inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis), gastric bypass surgery, atrophic gastritis, advanced liver disease, kidney dialysis)
  • 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)
  • Having a personal neural tube defect (NTD) history or a previous NTD pregnancy
  • Receiving ongoing blood transfusions
  • Currently smoking or having smoked in the past 3 months
  • Pre-pregnancy body mass index (BMI) ≥30 kg/m\^2
  • Allergy to any study supplement ingredients

Study Design

Enrollment

172 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Ferrous fumarate

24 mg elemental iron/day

experimental: Ferrous bisglycinate

24 mg elemental iron/day

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.

Primary outcome measure

  • Maternal ferritin concentration [ Time Frame: Blood sample collected at baseline (13-25 weeks gestation) and at follow-up (35-37 weeks gestation) ]

Central Contacts and Locations

Central contacts

Crystal Karakochuk, PhD

604-822-0421crystal.karakochuk@ubc.ca

Lulu Pei, MSc

604-822-0421lulu.pei@ubc.ca

Locations

BC Women's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Contacts

Lulu Pei, MSc

604-822-0421lulu.pei@ubc.ca

University of British Columbia, Food, Nutrition and Health Building

Recruiting

Vancouver, British Columbia, Canada, V6T 1Z4

Contacts

Lulu Pei, MSc

604-822-0421lulu.pei@ubc.ca

More Information

Sponsor

University of British Columbia

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Keywords

  • Iron
  • Pregnancy
  • Nutrition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-04-24.