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

February 21, 2020 updated by: Anemia Working Group Romania

Effects of Ascorbic Acid Administration in the Treatment of Anemia in Chronic Hemodialysed Patients With Iron Overload

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
Changes in ESA dose
Time Frame: 12 months
The number of reductions or increases in the ESA dose during the study
12 months
Variation in ESA dose
Time Frame: 12 months
The difference between the actual ESA dose and the one at baseline will be calculated monthly.
12 months
Variation of iron dose
Time Frame: 12 months
The difference between the actual iron dose and the one at baseline will be calculated monthly.
12 months
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.
12 months
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.
12 months
Variation of serum hepcidin
Time Frame: 12 months
Variation of serum hepcidin will be calculated every 3 months
12 months
Oxalemia
Time Frame: 12 months
Serum oxalate level will be calculated every 3 months
12 months
Local and general tolerance to vitamin C
Time Frame: 12 months
Local and general tolerance to vitamin C will be evaluated monthly
12 months
Adverse events
Time Frame: 12 months
Adverse events will be evaluated monthly
12 months
The number of withdrawals and dropouts
Time Frame: 12 months
The number of withdrawals and dropouts will be calculated monthly
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anemia Working Group Romania

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

August 23, 2014

First Submitted That Met QC Criteria

August 25, 2014

First Posted (Estimate)

August 26, 2014

Study Record Updates

Last Update Posted (Actual)

February 24, 2020

Last Update Submitted That Met QC Criteria

February 21, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AWGRO 06/2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Publication

IPD Sharing Time Frame

24 months

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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