Study of Neurocognitive and Brain Effects of Iron Deficiency Anemia in Adult Women and Response to Iron Therapy

What this Trial Is About

Researchers are studying adult women with moderate to severe iron deficiency anemia IDA and healthy controls to understand how IDA affects brain function and blood flow. The study aims to identify neurocognitive problems linked to IDA and examine changes in brain blood flow, vascular health, and blood-brain barrier function. It also investigates whether iron replacement therapy can reverse these brain and cognitive changes and how long these effects last. The study includes both observational and interventional parts. All participants undergo brain MRI scans, blood tests, patient surveys, and cognitive testing. In the interventional part, women with IDA are randomly assigned to receive either intravenous iron therapy Ferric Derisomaltose followed by daily oral iron Novaferrum or standard oral iron treatment through their primary care provider. A control group of healthy women participates only in the observational assessments. Tests are repeated over one year to monitor treatment effects and durability. Participants will attend multiple visits for MRI scans, blood work, symptom questionnaires, and neurocognitive tests. These assessments occur at baseline, 14 days, 90 days, 180 days, and one year after treatment starts. Researchers will measure brain oxygen delivery, blood flow, cognitive abilities, and quality of life, as well as iron levels and symptoms like restless legs syndrome. Safety is monitored throughout, and informed consent is required before joining. Total participation can last up to one year.

Iron Deficiency Anemia (IDA) and the Brain