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Ascorbic Acid Administration in the Treatment of Anemia in Chronic Hemodialysed Patients (FeVitC)

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ClinicalTrials.gov Identifier: NCT02225886
Recruitment Status : Not yet recruiting
First Posted : August 26, 2014
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Anemia Working Group Romania

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Anaemia Response to the Treatment Peripheral Iron Indices Oxalemia Drug: Ascorbic Acid Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Ascorbic Acid Administration in the Treatment of Anemia in Chronic Hemodialysed Patients With Iron Overload
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron Vitamin C

Arm Intervention/treatment
Experimental: 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.
Drug: 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

Placebo Comparator: 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.
Drug: 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




Primary Outcome Measures :
  1. Variation of erythropoetin resistance index (ERI) [ Time Frame: 12 months ]
    Erythropoietin resistance index: the dose of ESA divided by the level of Hb - will be calculated monthly.


Secondary Outcome Measures :
  1. Percentage of patients with Hb in the target range [ Time Frame: 12 months ]
    Percentage of patients with stable the hemoglobin in the target range (10.5-12g/dL), without any change in the weekly dose of ESA

  2. Changes in ESA dose [ Time Frame: 12 months ]
    The number of reductions or increases in the ESA dose during the study

  3. Variation in ESA dose [ Time Frame: 12 months ]
    The difference between the actual ESA dose and the one at baseline will be calculated monthly.

  4. Variation of iron dose [ Time Frame: 12 months ]
    The difference between the actual iron dose and the one at baseline will be calculated monthly.

  5. Percentage of patients with hemoglobin within target [ Time Frame: 12 months ]
    Percentage of patients with 10<Hb<12.1 g/dL will be calculated monthly.

  6. Percentage of patients with target iron status [ Time Frame: 12 months ]
    Percentage of patients with 100<serum ferritin<800 ng/mL and 19<transferrin saturation<51% will be calculated monthly.

  7. Variation of serum hepcidin [ Time Frame: 12 months ]
    Variation of serum hepcidin will be calculated every 3 months

  8. Oxalemia [ Time Frame: 12 months ]
    Serum oxalate level will be calculated every 3 months

  9. Local and general tolerance to vitamin C [ Time Frame: 12 months ]
    Local and general tolerance to vitamin C will be evaluated monthly

  10. Adverse events [ Time Frame: 12 months ]
    Adverse events will be evaluated monthly

  11. The number of withdrawals and dropouts [ Time Frame: 12 months ]
    The number of withdrawals and dropouts will be calculated monthly



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age above 18 years old
  • 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:

  • Active bleeding or other cause of anemia
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02225886


Contacts
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Contact: Liliana Garneata, MD, PhD +40722619358 liliana.garneata@gmail.com
Contact: Tudor Simionescu, MD PhD +40732161766 tudorsimi@yahoo.com

Locations
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Romania
"Nefrolab" Dialysis Center Not yet recruiting
Slatina, Romania
Contact: Aurelian Simionescu, MD, PhD    +40732161768    relusimionescu@yahoo.com   
Contact: Ileana Mihailescu, MD    +40730577485    dr_ilemih@yahoo.com   
Sponsors and Collaborators
Anemia Working Group Romania
Investigators
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Study Chair: Gabriel Mircescu, Professor Anemia Working Group Romania
Study Director: Liliana Garneata, MD, PhD Anemia Workiing Group Romania
Principal Investigator: Tudor Simionescu, MD, PhD "Carol Davila" Teaching Hospital of Nephrology

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Responsible Party: Anemia Working Group Romania
ClinicalTrials.gov Identifier: NCT02225886     History of Changes
Other Study ID Numbers: AWGRO 06/2014
First Posted: August 26, 2014    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: 24 months

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anemia Working Group Romania:
Renal anaemia
Intravenous ascorbic acid
Intravenous iron administration
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases
Ascorbic Acid
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamins