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Completed

NCT Number: NCT07076108

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Normal regimen of treatment of anemia

Drug

Patients were on normal regimen of treatment of anemia.

Vitamin C

Drug

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

Other names: 250 mg oral vitamin C

Primary outcomes

  1. Hemoglobin level

    Time frame: 3 months post-procedure

    Hemoglobin level was assessed every month for 3 months

Secondary outcomes

  1. Serum iron level

    Time frame: 3 months post-procedure

    Serum iron level was assessed every month for 3 months

  2. Transferrin saturation

    Time frame: 3 months post-procedure

    Transferrin saturation was assessed every month for 3 months

  3. Change in erythropoietin dose

    Time frame: 3 months post-procedure

    Change in erythropoietin dose was assessed every month for 3 months

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

The Safety and Efficacy of Oral Vitamin C Administration on Erythropoietin Dosing Requirement in End-Stage Renal Disease Patients on Regular Hemodialysis

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jul 21, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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