Overview

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

Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Anemia Working Group Romania
Treatments:
Ascorbic Acid
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