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

NCT06014983 | Recruiting

• 1 other identifier: H23-00016
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 2

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

Keywords

Iron; Pregnancy; Nutrition

Outcome Measures

Primary Outcomes (1)

• Maternal ferritin concentration

  µg/L; reflects body iron stores

  Blood sample collected at baseline (13-25 weeks gestation) and at follow-up (35-37 weeks gestation)

Secondary Outcomes (9)

• Maternal hemoglobin concentration

  Maternal blood sample collected at baseline (13-25 weeks gestation) and at follow-up (35-37 weeks gestation)

• Umbilical cord ferritin concentration

  Umbilical cord blood collected at time of delivery

• Umbilical cord hemoglobin concentration

  Umbilical cord blood collected at time of delivery

• Placental iron concentration

  Placenta collected at time of delivery

• Gut microbial analysis

  Stool sample collected at baseline (13-25 weeks gestation) and at follow-up (35-37 weeks gestation)

Study Arms (2)

Ferrous fumarate

ACTIVE COMPARATOR

24 mg elemental iron/day

Dietary Supplement: Ferrous fumarate

Ferrous bisglycinate

EXPERIMENTAL

24 mg elemental iron/day

Dietary Supplement: Ferrous bisglycinate

Interventions

Ferrous fumarate DIETARY_SUPPLEMENT

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

Ferrous fumarate

Ferrous bisglycinate DIETARY_SUPPLEMENT

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

Ferrous bisglycinate

Eligibility Criteria

• Age: 19 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant individual (singleton pregnancy)
• 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
• weeks gestation
• Willing to participate and able to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (2)

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

University of British Columbia, Food, Nutrition and Health Building

Vancouver, British Columbia, V6T 1Z4, Canada

RECRUITING

MeSH Terms

Conditions

Iron Deficiencies

Interventions

ferrous fumarate; ferrous bisglycinate

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Crystal Karakochuk, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Crystal Karakochuk, PhD

CONTACT

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

Lulu Pei, MSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 28, 2023
• Study Start: April 12, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)