TO DETERMINE THE EFFICACY OF LACTOFERRIN IN IMPROVING HEMOGLOBIN LEVELS IN CHRONIC KIDNEY DISEASE PATIENTS WITH IRON DEFICIENCY ANEMIA

Nutritional anemia i.e. iron deficiency anemia and CKD are prevalent in developing countries. CKD patient population has poor tolerance to oral iron as compared to healthy individuals and thus inadequate response to iron. This leads to complications like gastrointestinal side effects. Studies have shown that adding Lactoferrin to iron treatment improves iron deficiency anemia in pregnant women and patients with malignancy. Data on efficacy of this drug in the treatment of anemia in CKD is scarce. Hence we planned this study to compare add-on effect of Lactoferrin in improvement of anemia as against iron alone in iron deficiency CKD patients. The secondary objective was to compare change in inflammatory markers and adverse effects in the two arms of both treatment approaches.

Stable CKD patients with anemia were screened. Patients with T.Sat.< 20 mg/dL, Hb< 10 g/dL, stable creatinine for 3 months, stable erythropoietin dose, no new addition of hematinics in last 3 months were enrolled. Patients with hematological diseases, malignancy and chronic infection, receiving systemic immunosuppressive therapy at presentation were excluded from study. The two study groups were CKD patients on dialysis (CKD-5D) and those not on dialysis (CKDND). In each group, patients were randomised into two arms as follows; patients on Lactoferrin (100mg, twice daily) with iron treatment (Lac+ Fe group) and those on iron alone (Fe alone arm). The iron treatment consisted of oral liposomal iron tablets (30 mg, once daily). Clinical data i.e. CBC, RFT, iron profile, inflammatory markers were recorded and blood samples were collected at baseline and 3 month follow-up. Hepcidin was analysed by ELISA. Statistical analysis was done using paired t-test.

CKD5D group:

78 patients were enrolled in CKD5D group; 42 in Lac+ Fe arm and 36 in Fe alone arm completed the study. As shown in Table 1., there was significant improvement in Hb in both study arms, with higher improvement in Lac+ Fe arm as compared to Fe alone arm (p= 0.027). Change in hepcidin and ESR levels in the two arms (erythrocyte sedimentation rate) were insignificant (p= 0.052). The p value was significant for change in C reactive protein i.e. CRP (p= 0.031).

CKDND group:

68 patients were enrolled in CKDND group; 33 in Lac+ Fe arm and 35 in Fe alone arm completed the study. As shown in Table 2., higher improvement was seen in Lac+ Fe arm as compared to Fe alone arm (p= 0.038). Difference in hepcidin and inflammatory markers of C reactive protein (p= 0.16) and ESR (p=1.98) from baseline to follow up were not significant in the two arms.

In both study groups, magnitude of improvement in Hb was more in the Lac+ Fe arm than that of the Fe alone arm. No serious adverse effects was seen. In CKD5D group, 1 patient in each study arm reported mild gastritis. In the CKDND group, 2 patients in the Lac+ Fe arm and 1 patient in the Fe alone arm reported mild gastritis.