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Bovine Lactoferrin Compared With Ferrous sulfate for Treating Iron-Deficiency Anemia in Bangladeshi Women-A
Tanvir M Huda1, Sajia Islam2, Nazia Binte Ali3
1Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.
Background:
Lactoferrin is an iron-binding glycoprotein present in secretions, including breast milk, with anti-inflammatory and antimicrobial properties. Previous studies suggest bovine lactoferrin (bLF) may improve hemoglobin and iron status; however, most evidence comes from high-income countries, and data from resource-limited settings remain limited.
Objectives:
This study aimed to determine whether oral bLF is noninferior to ferrous sulfate for improving hemoglobin among nonpregnant women with iron-deficiency anemia (IDA) in Bangladesh. We hypothesized that 200 mg or 400 mg bLF would be noninferior to 60 mg elemental iron as ferrous sulfate after 12 wk, using a prespecified noninferiority margin of -0.25 g/dL.
Methods:
We conducted a double-blind, randomized, parallel-group, noninferiority trial in Dhaka, Bangladesh. Women aged 18 to 49 y with IDA were randomized 1:1:1 to receive 60 mg elemental iron as ferrous sulfate, 200 mg bLF, or 400 mg bLF, each given daily with 400 μg folic acid for 12 wk. Ferrous sulfate was the active control. The primary outcome was hemoglobin change from baseline to 12 wk in the per-protocol population.
Results:
Of 3722 women screened, 555 were randomly assigned to receive 186 to 200 mg bLF, 185 to 400 mg bLF, and 184 to ferrous sulfate. Mean hemoglobin change at 12 wk was -0.2 ± 0.8 g/dL, 0.0 ± 0.9 g/dL, and 1.1 ± 1.3 g/dL, respectively. Compared with ferrous sulfate, mean differences were -1.2 g/dL (95% CI: -1.6 to -0.9) and -1.1 g/dL (95% CI: -1.4 to -0.8) for 200 mg and 400 mg bLF, respectively (P < 0.0001). Adverse events were comparable across groups.
Conclusions:
In nonpregnant Bangladeshi women aged 18 to 49 y with IDA, both bLF doses were inferior to ferrous sulfate for improving hemoglobin after 12 wk. These findings do not support bLF as a substitute for ferrous sulfate in similar settings. This trial is registered with the Australian New Zealand Clinical Trials Registry as ACTRN12617001455358 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373059).