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

What this Trial Is About

Researchers are studying the effects of two different forms of iron supplements in pregnant individuals aged 19 to 42 years with generally low-risk pregnancies. The trial aims to determine which form of iron better increases iron levels in the mother and baby while assessing any potential side effects, including impacts on gut health. This randomized, double-blind study will help improve guidelines for iron supplementation during pregnancy to support both maternal and infant health. Participants will be randomly assigned to take either 24 mg of elemental iron daily as ferrous fumarate or ferrous bisglycinate, alongside a prenatal multivitamin without iron. Supplementation starts between 13 and 25 weeks of pregnancy and continues until delivery, with an optional extension up to about 4 weeks postpartum for breastmilk collection. The study includes a baseline visit, monthly surveys during pregnancy to monitor health changes, and a follow-up visit between 35 and 37 weeks gestation for supplement adherence and sample collection. During the study, participants will provide blood samples at baseline and follow-up to measure iron levels, stool samples to analyze gut microbiome changes, and optional breastmilk samples postpartum. Researchers will also collect umbilical cord blood and placenta samples at delivery. Monthly questionnaires will track any side effects or changes in health. The main outcome is maternal ferritin concentration, with several secondary measures including hemoglobin, gut microbiome, inflammation markers, and iron stores in breastmilk. Participation lasts from early pregnancy through delivery, with some optional postpartum involvement.

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