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

Not Applicable

Completed

• Conditions: Vitamin C; Oral Administration; Erythropoietin; End-Stage Renal Disease; Regular Hemodialysis
• Interventions: Drug: Vitamin C; Drug: Normal regimen of treatment of anemia

• Registration Number: NCT07076108
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2019-08-01
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01
• Status Verified: 2025-07
• Study First Submitted: 2025-07-13
• Study First Submitted QC: 2025-07-13
• Last Update Submitted: 2025-07-13
• Study First Posted: 2025-07-21
• Last Update Posted: 2025-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Vitamin C	Patients were on 250 mg oral vitamin C daily for 3 months.
Group A	Normal regimen of treatment of anemia	Patients were on normal regimen of treatment of anemia.
Group C	Vitamin C	Patients were on 500 mg oral vitamin C daily for 3 months.

Primary Outcome Measures

Name	Time	Method
Hemoglobin level	3 months post-procedure	Hemoglobin level was assessed every month for 3 months

Secondary Outcome Measures

Name	Time	Method
Serum iron level	3 months post-procedure	Serum iron level was assessed every month for 3 months
Transferrin saturation	3 months post-procedure	Transferrin saturation was assessed every month for 3 months
Change in erythropoietin dose	3 months post-procedure	Change in erythropoietin dose was assessed every month for 3 months

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt