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

NCT ID: NCT07076108

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2024-04-28

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Patients were on normal regimen of treatment of anemia.

Group Type ACTIVE_COMPARATOR

Normal regimen of treatment of anemia

Intervention Type DRUG

Patients were on normal regimen of treatment of anemia.

Group B

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

Group Type EXPERIMENTAL

Vitamin C

Intervention Type DRUG

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

Group C

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

Group Type EXPERIMENTAL

Vitamin C

Intervention Type DRUG

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

Interventions

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Normal regimen of treatment of anemia

Patients were on normal regimen of treatment of anemia.

Intervention Type DRUG

Vitamin C

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

Intervention Type DRUG

Vitamin C

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

Intervention Type DRUG

Other Intervention Names

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250 mg oral vitamin C 500 mg oral vitamin C

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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marwa hassan

Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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252

Identifier Type: -

Identifier Source: org_study_id