Efficacy and Adverse Side Effects of Two Forms of Iron in Pregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age19-42
SponsorUniversity of British Columbia
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Ferrous fumarate
Dietary supplementParticipants will supplement with 24 mg elemental iron in the form of ferrous fumarate daily for a minimum of 12 weeks.
Ferrous bisglycinate
Dietary supplementParticipants will supplement with 24 mg elemental iron in the form of ferrous bisglycinate daily for a minimum of 12 weeks.
Treatment groups
172 Participants
are divided into 2 treatment groupsGroup A: Ferrous fumarateActive comparator 1 intervention
Group B: Ferrous bisglycinateExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maternal ferritin concentration
µg/L; reflects body iron stores
Time frame
Blood sample collected at baseline (13-25 weeks gestation) and at follow-up (35-37 weeks gestation)Secondary outcomes
1
Maternal hemoglobin concentration
g/L; obtained through a complete blood count
Time frame
Maternal blood sample collected at baseline (13-25 weeks gestation) and at follow-up (35-37 weeks gestation)2
Umbilical cord ferritin concentration
µg/L; proxy measure for newborn iron stores
Time frame
Umbilical cord blood collected at time of delivery3
Umbilical cord hemoglobin concentration
g/L; measured using a HemoCue device
Time frame
Umbilical cord blood collected at time of delivery4
Placental iron concentration
µg/g; reflects iron transfer to fetus
Time frame
Placenta collected at time of deliverySponsors and contacts
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Source ClinicalTrials.gov