Ascorbic Acid Administration in the Treatment of Anemia in Chronic Hemodialysed Patients

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

Sponsors

Lead Sponsor: Anemia Working Group Romania

Source 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.

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.

Overall Status Recruiting
Start Date February 1, 2020
Completion Date December 2023
Primary Completion Date March 2023
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Variation of erythropoetin resistance index (ERI) 12 months
Secondary Outcome
Measure Time Frame
Percentage of patients with Hb in the target range 12 months
Changes in ESA dose 12 months
Variation in ESA dose 12 months
Variation of iron dose 12 months
Percentage of patients with hemoglobin within target 12 months
Percentage of patients with target iron status 12 months
Variation of serum hepcidin 12 months
Oxalemia 12 months
Local and general tolerance to vitamin C 12 months
Adverse events 12 months
The number of withdrawals and dropouts 12 months
Enrollment 100
Condition
Intervention

Intervention Type: Drug

Intervention Name: Ascorbic Acid

Description: 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:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Liliana Garneata, MD, PhD

Phone: +40722619358

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: "Nefrolab" Dialysis Center Aurelian Simionescu, MD, PhD +40732161768 [email protected]
Location Countries

Romania

Verification Date

February 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Ascorbic acid

Type: Experimental

Description: Patients will receive a 300 mg intravenous ascorbic acid, 3 times a week, postdialysis, except for the dialysis sessions when iv iron is administered.

Label: Control group

Type: Placebo Comparator

Description: Patients will receive 100 mL saline solution, 3 times a week, with associated medication, except but the dialysis sessions when iv iron is administered.

Acronym FeVitC
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov