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

NCT07076108 | Completed

• 1 other identifier: 252
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Hemoglobin level

  Hemoglobin level was assessed every month for 3 months

  3 months post-procedure

Secondary Outcomes (3)

• Serum iron level

  3 months post-procedure

• Transferrin saturation

  3 months post-procedure

• Change in erythropoietin dose

  3 months post-procedure

Study Arms (3)

Group A

ACTIVE COMPARATOR

Patients were on normal regimen of treatment of anemia.

Drug: Normal regimen of treatment of anemia

Group B

EXPERIMENTAL

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

Drug: Vitamin C

Group C

EXPERIMENTAL

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

Drug: Vitamin C

Interventions

Normal regimen of treatment of anemia DRUG

Patients were on normal regimen of treatment of anemia.

Group A

Vitamin C DRUG

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

Also known as: 250 mg oral vitamin C

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: July 21, 2025
• Study Start: August 1, 2019
• Primary Completion: April 28, 2024
• Study Completion: April 28, 2024
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)