The Efficacy and Safety of High-Dose Cholecalciferol Therapy in Hemodialysis Patients.

Vitamin D deficiency and insufficiency are highly prevalent in CKD, affecting over 80% of hemodialysis (HD) patients and requiring therapeutic intervention. Nephrological societies suggest the administration of cholecalciferol according to the guidelines for the general population. The aim of the observational study was to evaluate the efficacy and safety of the therapy with a high dose of cholecalciferol in HD patients with 25(OH)D deficiency and insufficiency to reach the target serum 25(OH)D level > 30 ng/mL. A total of 22 patients (16 M), with an average age of 72.5 ± 13.03 years and 25(OH)D concentration of 13.05 (9.00-17.90) ng/mL, were administered cholecalciferol at a therapeutic dose of 70,000 IU/week (20,000 IU + 20,000 IU + 30,000 IU, immediately after each dialysis session). All patients achieved the target value > 30 ng/mL, with a mean time of 2.86 ± 1.87 weeks. In the first week, the target level of 25(OH)D (100%) was reached by 2 patients (9.09%), in the second week by 15 patients (68.18%), in the fourth week by 18 patients (81.18%), and in the ninth week by all 22 patients (100%). A significant increase in 1,25(OH)2D levels was observed during the study. However, only 2 patients (9.09%) achieved a concentration of 1,25(OH)2D above 25 ng/mL-the lower limit of the reference range. The intact PTH concentrations remained unchanged during the observation period. No episodes of hypercalcemia were detected, and one new episode of hyperphosphatemia was observed. In conclusion, our study showed that the administration of a high-therapeutic dose of cholecalciferol allowed for a quick, effective, and safe leveling of 25(OH)D concentration in HD patients.

Dietary supplement use among patients with chronic kidney disease.

BACKGROUND: Dietary supplements (DS) are available over the counter, but patients with impaired renal function are specifically at risk for toxicity when consuming certain DS. The aim of this study was to evaluate the prevalence and characteristics of DS use in patients with chronic kidney disease (CKD). MATERIAL AND METHODS: A cross-sectional, controlled DS use survey (22 questions) was conducted among 180 CKD patients (stage 1-5, dialysis, kidney transplant), with 60 patients without CKD serving as controls. RESULTS: DS use did not differ significantly between subjects with and without CKD, unless the CKD patients were on dialysis. In the CKD group, 20% admitted to use DS regularly and 22% did not take the mat all. In the controls, DS consumption was 17% and 13%, respectively (NS). The DS use was higher among women ascompared to men (89% vs. 70%; p < 0.005), and people living in cities versus those living in the country side (81% vs. 63%; p < 0.05). DS most commonly used were: vitamins, minerals, and herbs. Major indications for DS use included: musculoskeletal issues, general health improvement and prevention of urinary tract infections. Subgroup analyses revealed that dialysis patients were characterized by a significantly higher DS use in comparison to CKD stage 1-5 subjects and renal transplant recipients. The decision to introduce DS was made by the physician in 54% of cases; by a pharmacist in 9% of cases, and by the patients themselves in 37%. Only 21% of patients with CKD, and 27% of subjects without CKD, declared knowledge of any possible side-effects associated with DS (NS). CONCLUSIONS: The use of DS among patients with CKD is similar to patients without CKD, with the exception of those on dialysis. Vitamins and minerals were the most commonly reported DS consumed. The knowledge on potential side-effectof DS was limited to approximately one-fourth of those surveyed.

Blood coagulation unaffected by ozonated autohemotherapy in patients on maintenance hemodialysis.

BACKGROUND: Ozonated autohemotherapy (O(3)-AHT) is a clinically useful therapeutic procedure in hemodialyzed patients with peripheral arterial occlusive disease (PAOD). The majority of patients on dialysis are in a hypercoagulable state. Thrombotic complications are the major cause of morbidity and mortality in hemodialyzed patients. Effects of O(3)-AHT on blood coagulation were evaluated in 11 hemodialyzed patients affected by PAOD. METHODS: We performed an oxygen-controlled, crossover study in which nine sessions of autohemotherapy with oxygen administration (AHT) as a control were followed by nine sessions of O(3)-AHT. Blood coagulation was assessed by antithrombin III, activated partial thromboplastin time, prothrombin time, D-dimer and fibrinogen plasma concentrations. RESULTS: The extents of all the measured parameters after nine sessions of O(3)-AHT did not differ statistically from the values after nine sessions of AHT. Similarly, there were no differences in the measured variables after the first session of O(3)-AHT as compared to the values before therapy. We did not observe any thrombotic accidents during the study. CONCLUSIONS: O(3)-AHT with ozone concentration of 50 microg/mL and citrate as an anticoagulant does not influence blood coagualation parameters in hemodialyzed patients with PAOD.

Platelet function unaffected by ozonated autohaemotherapy in chronically haemodialysed patients.

BACKGROUND: The therapeutic use of ozone is still a controversial medical strategy due to the potential toxicity of ozone, which is recognized as a highly reactive oxidant. The reactive oxygen species are known to induce platelet aggregation, the process involved in the development of atherosclerosis and cardiovascular events. In the present study, the influence of ozonated autohaemotherapy (O3-AHT) on the platelet function was evaluated in chronically haemodialysed patients with peripheral arterial disease. METHODS: This was an oxygen-controlled, cross-over study, in which nine sessions of autohaemotherapy with oxygen administration as a control were followed by nine sessions of O3-AHT. The platelet function was assessed by the extent of spontaneous aggregation (SPA) and agonist-induced aggregation (AIPA), where different concentrations of adenosine were used as an agonist. RESULTS: There were no differences between SPA and AIPA assessed after nine sessions of O3-AHT and after nine sessions of autohaemotherapy with oxygen administration. SPA and AIPA did not change after the first session of O3-AHT as compared with the levels before this procedure. CONCLUSION: O3-AHT with ozone concentration of 50 microg/ml and citrate as an anticoagulant does not induce platelet aggregation.

Fistula function and dialysis adequacy during ozonotherapy in chronically hemodialyzed patients.

There are a variety of complications related to chronic hemodialysis treatment, including thrombosis in hemodialysis access leading to blood recirculation, and in turn to the deterioration in hemodialysis effectiveness. Given that ozone decreases blood viscosity, increases erythrocyte deformability, and inhibits coagulation, the periodic blood ozonation may be of benefit in the attenuation of these disturbances. To gain insight into this issue,we originally evaluated the impact of ozonated autohemotherapy on recirculation in arteriovenous fistula, hemodialysis adequacy, and the frequency of dialyzer reuse. Twelve chronically hemodialyzed patients with peripheral arterial disease were enrolled in the prospective, placebo-controlled study. Nine sessions of autohemotherapy with the exposure of blood to oxygen, as a control, and nine sessions of autohemotherapy where the blood is exposed to ozone in a concentration of 50 microg/mL are administered in a single-blind manner. Access recirculation is measured by means of spectral technology(Crit Line Monitor, HemaMetrics, Kaysville, UT, U.S.A.), and hemodialysis adequacy is calculated using the Daugirdas formula and expressed as the Kt/V index. The Kt/V index and the frequency of dialyzer reuse do not change after ozonated autohemotherapy. Recirculation decreases after ozonotherapy in the majority of patients.on average by 35.3%, but the change does not reach the level of statistical significance (P = 0.064). We demonstrate that ozonated autohemotherapy does not influence dialysis adequacy and the frequency of dialyzer reuse. The improvement of fistula function, expressed as a decrease in recirculation, is not significant, although seen in the majority of patients.

Ozonated autohemotherapy in patients on maintenance hemodialysis: influence on lipid profile and endothelium.

Ozonated autohemotherapy (O3-AHT) is used in the treatment of atherosclerotic ischemia of lower limbs (AILL). The impact of ozone on serum lipids and endothelium injury is of particular interest since these factors are important in the development of atherosclerotic lesions. To evaluate this issue, a prospective, placebo-controlled study was designed. Twelve hemodialyzed subjects with AILL received autohemotherapy with oxygen as a control followed by O3-AHT with ozone concentration of 50 micro g/ml. Serum lipids and plasma activity of von Willebrand factor (vWF) were measured. After O3-AHT, total cholesterol significantly decreased compared to the baseline (-8.34%) [P < 0.01]. LDL cholesterol was also significantly lower than the initial value (-17.71%) [P < 0.001]. No significant changes in the activity of vWF were found after the first session of O3-AHT and after all nine sessions of O3-AHT. The study demonstrated that O3-AHT did not affect deleteriously the endothelium in patients with chronic renal failure on maintenance hemodialysis. It may stimulate beneficial changes in serum lipid profile manifesting as a decrease in the total- and LDL-cholesterol levels.

No effects of ozonated autohemotherapy on inflammation response in hemodialyzed patients.

BACKGROUND: Ozone as a strong oxidant may induce an inflammatory response. AIM: The hypothesis was verified as to whether ozonated autohemotherapy using an ozone dose in therapeutic range changes the plasma concentration of C-reactive protein and interleukin-6, markers of inflammation. METHODS: In a controlled, single-blind, cross-over study, 12 chronically hemodialyzed patients with peripheral arterial disease were exposed to nine sessions of autohemotherapy with blood exposure to oxygen as a control followed by nine sessions of ozonated autohemotherapy with an ozone concentration of 50 microg/ml. RESULTS: There was no statistical difference between C-reactive protein levels at baseline (1.53 +/- 1.01 mg/l), after nine sessions of control autohemotherapy (1.48 +/- 0.96 mg/l), and after nine sessions of ozonated autohemotherapy (1.55 +/- 0.84 mg/l). There was also no statistical difference between the interleukin-6 serum concentration at baseline (438 +/- 118 pg/ml), after nine sessions of control autohemotherapy (444 +/- 120 pg/ml), and after nine sessions of ozonated autohemotherapy (466 +/- 152 pg/ml). CONCLUSION: The results of this study suggest that ozonated autohemotherapy using an ozone concentration of 50 microg/ml does not induce an inflammatory response.

Antioxidants: a possible role in kidney protection.

Oxidative stress contributes to the pathophysiology of kidney injury. Beneficial renal effects of some medications, such as angiotensin-converting enzyme inhibitors, angiotensin II type 1 receptor antagonists, calcium channel blockers, beta-blockers and lipid lowering agents depend at least partially on the ability to alleviate oxidative stress. The administration of various natural or synthetic antioxidants has been shown to be of benefit in prevention and attenuation of renal scaring in numerous animal models of kidney diseases. These include vitamins, N-acetylcysteine, alpha-lipoic acid, melatonin, dietary flavonoids and phytoestrogens, and many others. Human studies are limited in this regard. Under certain conditions, surprisingly, the antioxidant supplements may exhibit pro-oxidant properties and even worsen renal damage. To date, the evidence is insufficient to recommend antioxidant supplements in patients with kidney disease. Prospective, controlled clinical trials on safety and effectiveness of different therapeutic antioxidant strategies are indispensable.