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Iron Supplement

Iron Supplements for Iron Deficiency in Pregnancy (EASE-Iron Trial)

N/A

Recruiting

Led By Crystal Karakochuk, PhD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pregnant individual (singleton pregnancy) 19-42 years of age

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up placenta collected at time of delivery

Awards & highlights

EASE-Iron Trial Summary

This trial will investigate how different forms of iron affect pregnant people and their babies. Blood & gut samples will be taken to assess impact. Results will help inform optimal iron supplementation.

Who is the study for?

This trial is for healthy pregnant individuals aged 19-42 in Vancouver, expecting one baby and planning to deliver at BC Women's Hospital. They should be 13-25 weeks into their pregnancy and able to visit the University of British Columbia. Exclusions include a BMI ≥30, smoking recently, certain pre-existing conditions affecting iron levels, or use of specific medications.Check my eligibility

What is being tested?

The study tests two types of iron supplements: Ferrous fumarate and Ferrous bisglycinate taken with prenatal vitamins during pregnancy until delivery. The goal is to compare how each supplement affects body iron stores and gut bacteria presence by analyzing blood samples and rectal swabs from start till around week 37.See study design

What are the potential side effects?

Potential side effects may include gastrointestinal discomfort such as constipation or diarrhea, nausea, abdominal pain due to the iron supplements. These are common reactions when taking oral iron but can vary between individuals.

EASE-Iron Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am pregnant, between 19 and 42 years old, and expecting one baby.

EASE-Iron Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ blood sample collected at baseline (13-25 weeks gestation) and at endline (37 weeks gestation)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~blood sample collected at baseline (13-25 weeks gestation) and at endline (37 weeks gestation)

This trial's timeline: 3 weeks for screening, Varies for treatment, and blood sample collected at baseline (13-25 weeks gestation) and at endline (37 weeks gestation) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maternal ferritin concentration

Umbilical cord ferritin concentration

Secondary outcome measures

Adverse side effects

Breastmilk iron stores

Fecal calprotectin

+6 more

EASE-Iron Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Ferrous bisglycinateExperimental Treatment1 Intervention

24 mg elemental iron/day

Group II: Ferrous fumarateActive Control1 Intervention

24 mg elemental iron/day

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor

1,418 Previous Clinical Trials

2,466,910 Total Patients Enrolled

Crystal Karakochuk, PhDPrincipal InvestigatorUniversity of British Columbia

1 Previous Clinical Trials

60 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial accommodate individuals aged 45 and above?

"This study is recruiting individuals from the age of 19 to 42."

Answered by AI

Do I meet the criteria to be included in this research endeavor?

"Candidates between the ages of 19 and 42 who are pregnant can apply for this trial, with 208 total participants needed."

Answered by AI

Are there any remaining vacancies in this clinical investigation?

"This trial is not currently recruiting, according to the information hosted on clinicaltrials.gov; it was initially posted on October 1st 2023 and last updated September 7th 2023. Although this particular medical study isn't seeking participants at this time, there are an additional 160 trials actively enrolling patients right now."

Answered by AI

What aims is this clinical trial striving to achieve?

"This monitored experiment, which will span from the 13th to 37th week of gestation, seeks to measure Umbilical cord ferritin concentration. The secondary objectives are centered around quantifying Umbilical cord hemoglobin concentrations in g/L using a HemoCue device; Placental iron concentrations in µg/g that reflect fetal iron transfer; and finally Gut pathogen abundance as Ct values for determining harmful bacterial presence."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Crystal Karakochuk 2024. "Efficacy and Adverse Side Effects of Two Forms of Iron in Pregnancy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06014983.