Lactoferrin: A Promising New Player in Treatment of Iron Deficiency Anemia in Patients on Regular Hemodialysis: A Randomized Controlled Trial.

Hepcidin is secreted in inflammatory states as in patients on regular hemodialysis (HD). Therefore, novel agents modulating hepcidin secretion may have the potential to effectively reverse anemia in HD patients. Bovine milk derivative lactoferrin (BLF) is a glycoprotein that was found to decrease serum interleukin-6, therefore, having anti-inflammatory properties. Thus, it can downregulate hepcidin secretion in various inflammatory states including patients on regular HD, so improving iron absorption and utilization in those patients. In addition, BLF is a source of iron as each BLF molecule chelates two ferric ions. We started an interventional study. Seventy patients on regular HD with iron deficiency anemia received 100 mg of 20%-30% iron-saturated BLF (corresponding to 70-84 μg of elemental iron) orally b.i.d for 6 months. We compared those patients with another 70 patients on regular HD with iron deficiency anemia who were given 576 mg of ferrous glycine sulfate (corresponding to 100 mg of elemental iron) orally b.i.d for 6 months. BLF significantly decreased serum hepcidin level (from 340-350 ng/mL to 101-112 ng/mL), P <0.0001 and significantly increased hemoglobin (Hb) concentration (from 7.5-8.1 g/dL to 9.3-10 g/dL), P <0.0001, and transferrin saturation (TSAT) (from 5%-9% to 26%-31%), P <0.0001. Furthermore, ferrous glycine sulfate significantly decreased serum hepcidin level (from 335-350 ng/mL to 330--341 ng/mL), P <0.0001, and significantly increased Hb (from 7.5-8.1 to 7.6-8.5 g/dL), P <0.0001, and TSAT (from 5%-9% to 7%-12%), P <0.0001. However, the magnitude of decrease in serum hepcidin level and rise in Hb and TSAT in the BLF group was significantly higher than in the ferrous glycine sulfate group, P <0.0001. Oral BLF can be considered a promising novel agent in treatment of iron deficiency anemia in patients on regular HD.