Oral Vitamin C Administration on Erythropoietin Dosing Requirement in End-Stage Renal Disease Patients on Regular Hemodialysis

Ain Shams University

Status: Completed

Conditions: End-Stage Renal Disease; Regular Hemodialysis; Vitamin C; Oral Administration; Erythropoietin

Treatments: Drug: Vitamin C; Drug: Normal regimen of treatment of anemia

Study type: Interventional

Funder types: Other

Identifiers

NCT07076108

252

Details and patient eligibility

About

The study aimed to evaluate the safety and efficacy of oral vitamin C administration on erythropoietin dosing requirement in end-stage renal disease patients on regular hemodialysis.

Full description

Erythropoietin deficiency is the most significant cause of anemia in chronic kidney disease (CKD) and has been demonstrated to occur at each stage of kidney failure. Because the kidney is the sole source of erythropoietin (EPO) synthesis in adults, reduction in kidney mass as occurs in progressive CKD often results in impairment of EPO production, resulting in anemia.

Vitamin C deficiency can interfere with iron absorption and utilization, as well as lead to various abnormalities. The occurrence of widespread vitamin C deficiency in dialysis patients calls for greater attention to these clinical problems. Ascorbic acid is low in patients with advanced CKD and end-stage renal disease (ESRD) due to dietary restrictions on vitamin C-rich foods, as these foods are usually also rich in potassium.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >18 years.
• Both sexes.
• Stable hemodialysis (HD) for 90 days or more
• Hemoglobin (HB) levels of 9-11 g/dL (as Hb levels above 11 g/dL, Epo dose reduction is recommended irrespective of iron level).
• Erythropoietin (EPO) dose ≥4000 U/HD session and unchanged dose for two consecutive months
• Ferritin level >100 mcg/L.
• Transferrin saturation (Tsat) of <30 %.
• Not on a vitamin C supplement.
• Not receiving iron supplementation in the preceding 2 months. Each patient's previous 2-month stable dose of Epo was taken as the control.

Exclusion criteria

• Patients with gastrointestinal bleeding.
• Blood transfusion, malignancy.
• Hospital admission or history of noncompliance with dialysis and/or medication were excluded from the study and were also censored if these events occurred during the study period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Group A

Active Comparator group

Description:

Patients were on normal regimen of treatment of anemia.

Treatment:

Drug: Normal regimen of treatment of anemia

Group B

Experimental group

Description:

Patients were on 250 mg oral vitamin C daily for 3 months.

Treatment:

Drug: Vitamin C

Drug: Vitamin C

Group C

Experimental group

Description:

Patients were on 500 mg oral vitamin C daily for 3 months.

Treatment:

Drug: Vitamin C

Drug: Vitamin C