The administration of ascorbic acid seemed to increase the iron available for erythropoiesis, thus improving the anemia response to the treatment. The investigators therefore aimed to evaluate the effects of intravenous ascorbic acid administration in hemodialysed patients with iron overload.
Renal anemia is a complex condition in which chronic inflammation, among other factors, can change the iron distribution by locking it in deposits, and also, iron metabolism parameters. Thus, is hard to separate the iron functional deficit from overload. The ascorbic acid is a hydrosoluble vitamin capable of reduction and hydrolysis. As a reduction agent, the ascorbic acid supports the transformation of ferric iron to ferrous iron. For instance, the ascorbic acid can increase digestive absorption and taking over the iron without transferrin, helps iron release from ferritin and hemosiderin and delays ferritin conversion to hemosiderin; therefore, the administration of ascorbic acid can increase the quantity of iron available for erythropoiesis by realising it from the deposits. Consequently, the antioxidant function of ascorbic acid can increase the red cells' lifetime, reducing the inflammation and improving erythropoietin response Following these premises, recent studies have examined the effect of administrating ascorbic acid to hemodialysed patients with erythropoiesis stimulating agents (ESA) hyporesponsiveness anemia and functional deficit or iron overload markers. The results of administering ascorbic acid revealed an increased level of hemoglobin and transferrin saturation (TSAT) combined with the decrease of ESA doses. The major limitations of these studies are the short amount of time for observation (\<6months) and the limited number of participants which hampered neither the complete evaluation of the goals, nor the adverse effects of supplementary administration of vitamin C. Until now, the Clinical practice guidelines of Kidney Disease do not recommend currently using of high doses of vitamin C, considering the risk of a high level of oxalemia and the limited information about the benefits. Considering this background, we intended to evaluate the benefits of intravenous administration of ascorbic acid in hemodialysed patients with iron balance markers suggestive for iron overload.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
300 mg of intravenous ascorbic acid will be given 3 times a week, postdialysis, in 100 mL saline solution, except for the dialysis sessions when iv iron is administered
"Nefrolab" Dialysis Center
Slatina, Romania
RECRUITINGVariation of erythropoetin resistance index (ERI)
Erythropoietin resistance index: the dose of ESA divided by the level of Hb - will be calculated monthly.
Time frame: 12 months
Percentage of patients with Hb in the target range
Percentage of patients with stable the hemoglobin in the target range (10.5-12g/dL), without any change in the weekly dose of ESA
Time frame: 12 months
Changes in ESA dose
The number of reductions or increases in the ESA dose during the study
Time frame: 12 months
Variation in ESA dose
The difference between the actual ESA dose and the one at baseline will be calculated monthly.
Time frame: 12 months
Variation of iron dose
The difference between the actual iron dose and the one at baseline will be calculated monthly.
Time frame: 12 months
Percentage of patients with hemoglobin within target
Percentage of patients with 10\<Hb\<12.1 g/dL will be calculated monthly.
Time frame: 12 months
Percentage of patients with target iron status
Percentage of patients with 100\<serum ferritin\<800 ng/mL and 19\<transferrin saturation\<51% will be calculated monthly.
Time frame: 12 months
Variation of serum hepcidin
Variation of serum hepcidin will be calculated every 3 months
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Time frame: 12 months
Oxalemia
Serum oxalate level will be calculated every 3 months
Time frame: 12 months
Local and general tolerance to vitamin C
Local and general tolerance to vitamin C will be evaluated monthly
Time frame: 12 months
Adverse events
Adverse events will be evaluated monthly
Time frame: 12 months
The number of withdrawals and dropouts
The number of withdrawals and dropouts will be calculated monthly
Time frame: 12 months