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Randomized Controlled Trial Comparing Lactoferrin Plus Iron to Iron Alone for Iron Deficiency Anemia in CKD
Smita Divyaveer1, Kushal Kekan1, Madhuri Kashyap1
1Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Background:
Lactoferrin, a multifunctional iron-binding glycoprotein with anti-inflammatory properties is reported to be effective in anemia in pregnant women and patients with malignancy but has not been tested elaborately in CKD.
Methods:
In this randomized, open-label trial, 185 patients (intention to treat) with iron-deficiency anemia (hemoglobin less than 10 g/dL, transferrin saturation less than 20%) were enrolled: 90 with CKD not on dialysis (CKD-ND) and 95 with dialysis-dependent CKD (CKD-5D). Patients were randomized to receive either oral iron (30 mg/day liposomal iron) or oral iron plus lactoferrin (100 mg twice daily) for 3 months. The primary outcome was change in hemoglobin. Secondary outcomes included iron indices and inflammatory markers (CRP, IL-6, ESR, hepcidin).
Results:
In the intention-to-treat analysis, lactoferrin plus iron resulted in significantly greater improvements in hemoglobin and iron parameters than iron alone in both CKD-ND and CKD-5D patients. Mean hemoglobin increased by 1.95±1.19 versus 1.33±0.86 g/dL in CKD-ND and by 1.73±0.96 versus 1.11±0.93 g/dL in CKD-5D patients receiving lactoferrin plus iron and iron alone, respectively. Improvements in iron indices were also greater with addon lactoferrin treatment. Mean difference in hepcidin levels were -20.24±15.99 vs -16.03±40.65 ng/dL in CKD-ND and -15.29±8.73 vs -20.99±20.16 ng/dL in CKD-5D patients treated with lactoferrin plus iron and iron alone respectively.
Conclusion:
Among patients with CKD-associated anemia, adjunctive lactoferrin therapy improved hemoglobin and iron parameters compared with oral iron alone in both non-dialysis-dependent and dialysis-dependent patients. Lactoferrin was also associated with modest improvements in inflammatory status, although effects on individual inflammatory markers were inconsistent. These findings suggest that lactoferrin may be a useful adjunct to oral iron therapy for the management of anemia in CKD especially in resource limited settings.
