Study of Iron Absorption Using Stabilized Lactoferrin in Women with Iron Deficiency Without Anemia, Ages 18 to 45

What this Trial Is About

Researchers are investigating how encapsulating lactoferrin LF, a natural iron-binding protein found in milk, might protect it from digestion and improve iron absorption in women with iron deficiency without anemia. The study focuses on whether apo-LF, either alone or combined with iron, can be stabilized to maintain its function during digestion. This research uses a randomized crossover design to compare different encapsulation methods to find the best way to enhance iron absorption in iron-deficient women aged 18 to 45 years. Participants will receive different test compounds labeled with stable iron isotopes. These include combinations of ferrous sulfate and lactoferrin in native or encapsulated forms using sodium caseinate or low methoxy pectin, given with a test meal or water. Each participant will consume these compounds in a randomized order, allowing direct comparison of iron absorption from various formulations. During the study, researchers will measure fractional iron absorption by tracking the incorporation of labeled iron into red blood cells 17 days after each dose. Additional blood tests will monitor hemoglobin, serum ferritin, soluble transferrin receptor, C-reactive protein, and alpha-1-acid glycoprotein levels at multiple time points. The study involves several visits over a period extending to 64 days, with safety monitoring and assessment of iron status throughout.

Absorption of Iron From Stabilized Lactoferrin: A Study in Women With Iron Deficiency