PregnancyEASE-IronNCT06014983
Efficacy and Adverse Side Effects of Two Forms of Iron in Pregnancy
A study testing Ferrous fumarate and Ferrous bisglycinate in people with Pregnancy and Iron Deficiency, run by University of British Columbia at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Iron Deficiency
- What is being tested?
- Ferrous fumarate and Ferrous bisglycinate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 2 sitesCanada
- Study dates
- 12 Apr 2024to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
BC Women's Hospital
Vancouver, British Columbia, V6H 3N1
Lulu Pei, MSc, 604-822-0421, lulu.pei@ubc.ca
- Recruiting
University of British Columbia, Food, Nutrition and Health Building
Vancouver, British Columbia, V6T 1Z4
Lulu Pei, MSc, 604-822-0421, lulu.pei@ubc.ca
About this study
Official title: Efficacy and Adverse Side Effects of Two Forms of Iron in Prenatal Micronutrient Supplements (EASE-Iron): A Randomized Controlled Trial
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.
Read the detailed description
To address our primary aim of determining the optimal form of iron in prenatal supplements, we seek to answer the following research questions:
- Does providing a more bioavailable form of iron (24 mg elemental iron as ferrous bisglycinate) effectively increase ferritin concentration in maternal venous blood and umbilical cord blood, as compared to the standard 24 mg elemental iron as ferrous fumarate?
- Does 12 weeks of 24 mg daily oral iron as ferrous fumarate increase biomarkers of potential harm (adverse side effects, gut microbiome composition, gut inflammation) in pregnant individuals, as compared to 24 mg daily oral iron as ferrous bisglycinate?
Pregnant individuals 13-25 weeks gestation will be randomized to one of two trial arms to receive either 24 mg elemental iron as ferrous fumarate or 24 mg elemental iron as ferrous bisglycinate for a minimum of 12 weeks during pregnancy until delivery, with optional continuation until 4-weeks postpartum for breastmilk collection. All participants will also receive the standard form and dose of other critical micronutrients during pregnancy (e.g., folic acid, calcium) through the provision of a prenatal multivitamin (not containing iron).
Interested individuals may undergo the informed consent process anytime prior to 25 weeks gestation. Once an individual indicates that they are interested in participating in the trial, the individual will be assigned a unique study ID and a baseline visit will be scheduled.
The baseline visit will occur between 13-25 weeks gestation and will involve discontinuation of current iron/prenatal vitamin supplementation, review and signing the informed consent form (a scanned copy will be shared with the participant), randomization to an iron group, provision of study supplements, completion of a baseline questionnaire, measurement of weight and height, a small blood draw, and provision of a stool collection kit for at-home stool collection.
The intervention period is a minimum of 12 weeks (from baseline at 13-25 weeks to delivery). Participants will supplement daily with the iron and prenatal multivitamin supplements. Monthly follow-up surveys will be sent to participants via email to check-in and receive updates regarding any changes to medical history or medication use.
The follow-up visit will occur between 35-37 weeks gestation and will involve collecting any remaining supplements (for capsule counts and assessment of adherence), a weight measurement, a small blood draw, provision of at-home stool collection kit, and completion of a short follow-up questionnaire.
Optional continuation of study: After the follow-up visit, participants who are planning to breastfeed will have the option to continue supplementing with the study supplements and provide a prenatal colostrum sample and/or 4-week postpartum breastmilk sample.
- Conditions
- Pregnancy, Iron Deficiency
- Being tested
- Ferrous fumarate, Ferrous bisglycinate
- Keywords
- Iron, Pregnancy, Nutrition
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous fumarateDietary supplement
Participants will supplement with 24 mg elemental iron in the form of ferrous fumarate daily for a minimum of 12 weeks.
Ferrous bisglycinateDietary supplement
Participants will supplement with 24 mg elemental iron in the form of ferrous bisglycinate daily for a minimum of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Ferrous fumarate | Active comparator | 24 mg elemental iron/day Receives: Dietary Supplement: Ferrous fumarate |
| Ferrous bisglycinate | Experimental | 24 mg elemental iron/day Receives: Dietary Supplement: Ferrous bisglycinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal ferritin concentration
µg/L; reflects body iron stores
Measured: Blood sample collected at baseline (13-25 weeks gestation) and at follow-up (35-37 weeks gestation)
Secondary outcomes (9)
Maternal hemoglobin concentration
g/L; obtained through a complete blood count
Measured: Maternal blood sample collected at baseline (13-25 weeks gestation) and at follow-up (35-37 weeks gestation)
Umbilical cord ferritin concentration
µg/L; proxy measure for newborn iron stores
Measured: Umbilical cord blood collected at time of delivery
Umbilical cord hemoglobin concentration
g/L; measured using a HemoCue device
Measured: Umbilical cord blood collected at time of delivery
Placental iron concentration
µg/g; reflects iron transfer to fetus
Measured: Placenta collected at time of delivery
Gut microbial analysis
16S rRNA gene sequencing and targeted real-time PCR (qPCR); gut microbiome composition
Measured: Stool sample collected at baseline (13-25 weeks gestation) and at follow-up (35-37 weeks gestation)
Adverse side effects
Includes reported gastrointestinal side effects (e.g., constipation, diarrhea, nausea) and any other side effects experienced
Measured: Follow-up (35-37 weeks gestation)
Markers of inflammation
Includes alpha-1 acid glycoprotein (AGP; g/L) and C-reactive protein (CRP; mg/L), used in combination to adjust ferritin concentration
Measured: Maternal blood sample collected at baseline (13-25 weeks gestation) and at follow-up (35-37 weeks gestation); umbilical cord blood sample collected at time of delivery
Hepcidin concentration
nmol/L; hormone that influences iron regulation
Measured: Maternal blood sample collected at baseline (13-25 weeks gestation) and at follow-up (35-37 weeks gestation); umbilical cord blood sample collected at time of delivery
Breastmilk iron stores
Includes measurement of breastmilk iron content (mg/mL) and lactoferrin (mg/mL)
Measured: Breastmilk sample collected at 4-weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start12 Apr 2024
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Crystal Karakochuk, University of British Columbia
- Investigators
- Crystal Karakochuk, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014983
- Sponsor's protocol ID
- H23-00016
- Acronym
- EASE-Iron
- Status last verified
- Apr 2026
- First submitted
- 22 Aug 2023
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon reasonable request, the Principal Investigator will share de-identified individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Adverse Side Effects of Two Forms of Iron in Prenatal Micronutrient Supplements (EASE-Iron): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06014983
- Acronym / sponsor ID
- EASE-Iron / H23-00016
- Conditions
- Pregnancy, Iron Deficiency
- Keywords
- Iron, Pregnancy, Nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 12 Apr 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To address our primary aim of determining the optimal form of iron in prenatal supplements, we seek to answer the following research questions:
- Does providing a more bioavailable form of iron (24 mg elemental iron as ferrous bisglycinate) effectively increase ferritin concentration in maternal venous blood and umbilical cord blood, as compared to the standard 24 mg elemental iron as ferrous fumarate?
- Does 12 weeks of 24 mg daily oral iron as ferrous fumarate increase biomarkers of potential harm (adverse side effects, gut microbiome composition, gut inflammation) in pregnant individuals, as compared to 24 mg daily oral iron as ferrous bisglycinate?
Pregnant individuals 13-25 weeks gestation will be randomized to one of two trial arms to receive either 24 mg elemental iron as ferrous fumarate or 24 mg elemental iron as ferrous bisglycinate for a minimum of 12 weeks during pregnancy until delivery, with optional continuation until 4-weeks postpartum for breastmilk collection. All participants will also receive the standard form and dose of other critical micronutrients during pregnancy (e.g., folic acid, calcium) through the provision of a prenatal multivitamin (not containing iron).
Interested individuals may undergo the informed consent process anytime prior to 25 weeks gestation. Once an individual indicates that they are interested in participating in the trial, the individual will be assigned a unique study ID and a baseline visit will be scheduled.
The baseline visit will occur between 13-25 weeks gestation and will involve discontinuation of current iron/prenatal vitamin supplementation, review and signing the informed consent form (a scanned copy will be shared with the participant), randomization to an iron group, provision of study supplements, completion of a baseline questionnaire, measurement of weight and height, a small blood draw, and provision of a stool collection kit for at-home stool collection.
The intervention period is a minimum of 12 weeks (from baseline at 13-25 weeks to delivery). Participants will supplement daily with the iron and prenatal multivitamin supplements. Monthly follow-up surveys will be sent to participants via email to check-in and receive updates regarding any changes to medical history or medication use.
The follow-up visit will occur between 35-37 weeks gestation and will involve collecting any remaining supplements (for capsule counts and assessment of adherence), a weight measurement, a small blood draw, provision of at-home stool collection kit, and completion of a short follow-up questionnaire.
Optional continuation of study: After the follow-up visit, participants who are planning to breastfeed will have the option to continue supplementing with the study supplements and provide a prenatal colostrum sample and/or 4-week postpartum breastmilk sample.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferrous fumarate | Active comparator | Dietary Supplement: Ferrous fumarate24 mg elemental iron/day |
| Ferrous bisglycinate | Experimental | Dietary Supplement: Ferrous bisglycinate24 mg elemental iron/day |
Who may qualify
- Ages
- 19 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferrous fumarateParticipants will supplement with 24 mg elemental iron in the form of ferrous fumarate daily for a minimum of 12 weeks. | Dietary supplement | Ferrous fumarate |
| Ferrous bisglycinateParticipants will supplement with 24 mg elemental iron in the form of ferrous bisglycinate daily for a minimum of 12 weeks. | Dietary supplement | Ferrous bisglycinate |
Primary outcome
Maternal ferritin concentration
Time frame: Blood sample collected at baseline (13-25 weeks gestation) and at follow-up (35-37 weeks gestation)
µg/L; reflects body iron stores
9 secondary outcomes
Maternal hemoglobin concentration
Time frame: Maternal blood sample collected at baseline (13-25 weeks gestation) and at follow-up (35-37 weeks gestation)
Umbilical cord ferritin concentration
Time frame: Umbilical cord blood collected at time of delivery
Umbilical cord hemoglobin concentration
Time frame: Umbilical cord blood collected at time of delivery
Placental iron concentration
Time frame: Placenta collected at time of delivery
Gut microbial analysis
Time frame: Stool sample collected at baseline (13-25 weeks gestation) and at follow-up (35-37 weeks gestation)
Adverse side effects
Time frame: Follow-up (35-37 weeks gestation)
Markers of inflammation
Time frame: Maternal blood sample collected at baseline (13-25 weeks gestation) and at follow-up (35-37 weeks gestation); umbilical cord blood sample collected at time of delivery
Hepcidin concentration
Time frame: Maternal blood sample collected at baseline (13-25 weeks gestation) and at follow-up (35-37 weeks gestation); umbilical cord blood sample collected at time of delivery
Breastmilk iron stores
Time frame: Breastmilk sample collected at 4-weeks postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No. Upon reasonable request, the Principal Investigator will share de-identified individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Crystal Karakochuk, PhD principal investigator
University of British Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferrous fumarate and Ferrous bisglycinate in people with Pregnancy and Iron Deficiency, run by University of British Columbia at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Crystal Karakochuk, PhD (604-822-0421, crystal.karakochuk@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.