Effect of Paricalcitol vs Calcitriol on Hemoglobin Levels in Chronic Kidney Disease Patients: A Randomized Trial

Abstract

BackgroundRecent studies suggest that vitamin D deficiency represents an additional cofactor of renal anemia, with several mechanisms accounting for this relationship. In line with it, the administration of vitamin D or its analogues has been associated with an improvement of anemia. There are no data, however, about a direct effect of paricalcitol on hemoglobin (Hb) levels. Therefore, we conducted a study to determine whether paricalcitol, compared to calcitriol, improves anemia in patients with chronic kidney disease (CKD).MethodsIn this randomized trial 60 CKD patients stage 3b-5 and anemia (Hb levels: 10-12.5 g/dL) were assigned (1:1) to receive low doses of calcitriol (Group Calcitriol) or paricalcitol (Group Paricalcitol) for 6 months. All the patients had normal values of plasma calcium, phosphorus and PTH, a stable iron balance, and normal values of C-Reactive Protein. The primary endpoint was to evaluate the effects of the two treatments on Hb levels; the modifications in 24hr-proteinuria (UProt) were also evaluated.ResultsA significant Group x Time interaction effect was observed in the longitudinal analysis of Hb levels (F(1,172)=31.4, p<0.001). Subjects in Paricalcitol experienced a significant monthly increase of Hb levels equal to +0.16 g/dL [95% C.I. 0.10 to +0.22, p<0.001) while in Group Calcitriol, Hb decrease throughout the follow-up with an average monthly rate of -0.10 g/dL (95% C.I.: -0.17 to -0.04, p<0.001). In Group Paricalcitol, UProt was significantly reduced after 6 months [0.35 (0.1-1.2) vs 0.59 (0.2-1.6), p<0.01], whereas no significant difference emerged in Group Calcitriol. Plasma levels of calcium, phosphate, PTH and of inflammation markers remained in the normal range in both groups throughout the study.ConclusionsShort-term exposure to paricalcitol results in an independent increase in Hb levels, which occurred with no modification of iron balance, inflammatory markers, and PTH plasma concentrations, and was associated with a decrease in UProt.Trial RegistrationClinicalTrials.gov NCT01768351

Correlation Between Levels of 25-Hydroxy-Vitamin D and Degree of Anemia in Patients with Chronic Kidney Disease

“…Riccio et al [15] also demonstrated that paricalcitol exhibited beneficial effects on hemoglobin levels in patients with advanced-stage CKD, independently of other factors such as inflammation or PTH levels.…”

High-dose vitamin D 3 reduces circulating hepcidin concentrations: A pilot, randomized, double-blind, placebo-controlled trial in healthy adults

“…Among those that have, the results have been mixed, likely due to the differences in dosage and form of vitamin D administered, and the population studied [26-28]. In studies of patients with CKD, vitamin D or its analogues have been shown to increase hemoglobin concentrations [27, 29-31]. Larger studies examining the effect of vitamin D administration on circulating hepcidin concentrations, and the subsequent impact on hemoglobin concentrations or anemia in both healthy and diseased populations at risk for anemia are necessary.…”

Vitamin D Status Is Associated with Hepcidin and Hemoglobin Concentrations in Children with Inflammatory Bowel Disease

“…This is consistent with several studies in chronic kidney disease, cardiovascular disease, and the general population, which have described a positive association between vitamin D status and hemoglobin and/or an inverse association between vitamin D status and anemia (9–13, 15, 39, 40). Data from clinical trials have been mixed (39–42), but recent studies in CKD and critically ill adult patient populations found that treatment with vitamin D or its analogues resulted in significant increases in hemoglobin concentrations (24, 43). This association has not been previously studied in IBD animal models or clinical studies.…”