Impact of vitamin D3 intake on hemoglobin levels and erythropoietin response in patients on hemodialysis: a randomized single blinded trial

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Abstract
Purpose: Patients on regular hemodialysis (HD) are at the highest risk of developing anemia. Vitamin D deficiency is more prevalent in HD patients. Recent studies have suggested that improving vitamin D status can reduce both anemia and the need for higher recombinant human erythropoietin (EPO) dosing. This study is to demonstrate the pleiotropic effects of two regimens of cholecalciferol intake on the hemoglobin (Hgb) levels, ferritin levels, transferrin saturation (TSAT), total iron-binding capacity (TIBC) and the erythropoietin sensitivity index (ERI) in HD patients. Methods: A prospective, randomized, single blinded trial was conducted to evaluate the effect of weekly versus monthly cholecalciferol administration on anemia parameters and erythropoietin sensitivity in hemodialysis (HD) patients. Fifty eligible patients undergoing HD were randomly allocated to receive either weekly doses of 50,000 IU or monthly doses of 200,000 IU cholecalciferol. Various parameters including Hgb levels, ferritin levels, TSAT, TIBC, ERI, and cumulative dose of erythropoietin (EPO) were evaluated both at baseline and at endpoint. This study was registered at Clinicaltrial.gov, identifier number (NCT05922696), registered 2023/06/20 (Retrospectively registered). Results: Adding weekly or monthly cholecalciferol to standard HD care for three months resulted in a 72% reduction in EPO doses for thirty-six out of fifty patients. Both regimens significantly increased Hgb levels, with the weekly regimen showing a greater increase (+ 2.67 g/dl vs. + 0.70 g/dl; P < 0.001). The weekly regimen also led to a significant increase in TSAT (P = 0.005) and a decrease in ferritin levels (P = 0.03). Moreover, the weekly regimen significantly reduced EPO doses (−11,600 IU vs. −6,160 IU) and ERI (−4.76 vs. −2.68; P < 0.001) compared to the monthly regimen. Conclusion: Cholecalciferol demonstrated a beneficial impact on anemia in HD patients. Weekly 50,000 IU regimen had better control over Hgb, TSAT, TIBC, EPO dosing, and erythropoietin sensitivity compared to the monthly 200,000IU regimen. ClinicalTrials.gov registration number: NCT05922696.

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