Ascorbic Acid Administration in the Treatment of Anemia in Chronic Hemodialysed Patients
NCT ID: NCT02225886
Last Updated: 2020-02-24
Study Results
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Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2020-02-01
2023-12-31
Brief Summary
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The investigators therefore aimed to evaluate the effects of intravenous ascorbic acid administration in hemodialysed patients with iron overload.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ascorbic acid
Patients will receive a 300 mg intravenous ascorbic acid, 3 times a week, postdialysis, except for the dialysis sessions when iv iron is administered.
Ascorbic Acid
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
Control group
Patients will receive 100 mL saline solution, 3 times a week, with associated medication, except but the dialysis sessions when iv iron is administered.
Ascorbic Acid
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
Interventions
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Ascorbic Acid
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
Eligibility Criteria
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Inclusion Criteria
* At least 6 months on hemodialysis at the time of randomization;
* Kt/V≥1.2;
* average of the last three serum ferritin levels \> 500 ng/mL AND
* Average of the last three TSAT levels \> 20% and increasing
* ERI in the 4th quartile of the group
Exclusion Criteria
* Serum level of intact parathyroid hormone (iPTH)\>800 pg/mL
* Actual neoplasia
* HIV, Hepatitis B or C infections
* Significant inflammation (CRP\>12mg/L) or acute infection
* Venous central catheter
* Severe hepatic, cardiovascular, psychic disease or other severe comorbidities
* Moderate or severe malnutrition
* Blood transfusions in the 2 months prior to screening
* Pregnancy or breastfeeding
* Inclusion in another clinical trial in the past month
18 Years
85 Years
ALL
No
Sponsors
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Anemia Working Group Romania
OTHER
Responsible Party
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Principal Investigators
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Gabriel Mircescu, Professor
Role: STUDY_CHAIR
Anemia Working Group Romania
Liliana Garneata, MD, PhD
Role: STUDY_DIRECTOR
Anemia Workiing Group Romania
Tudor Simionescu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
"Carol Davila" Teaching Hospital of Nephrology
Locations
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"Nefrolab" Dialysis Center
Slatina, , Romania
Countries
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Central Contacts
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Facility Contacts
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References
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Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.
Other Identifiers
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AWGRO 06/2014
Identifier Type: -
Identifier Source: org_study_id
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