Efficacy and Adverse Side Effects of Two Forms of Iron in Prenatal Micronutrient Supplements (EASE-Iron): A Randomized Controlled Trial

NCT06014983 NA RECRUITING

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.

Details

Lead sponsor	University of British Columbia
Phase	NA
Status	RECRUITING
Enrolment	172
Start date	2024-04-12
Completion	2027-01

Conditions

• Pregnancy
• Iron Deficiency

Interventions

• Ferrous fumarate
• Ferrous bisglycinate

Primary outcomes

• Maternal ferritin concentration — Blood sample collected at baseline (13-25 weeks gestation) and at follow-up (35-37 weeks gestation)
  µg/L; reflects body iron stores

Countries

Canada