Vitamin CNCT07076108
Oral Vitamin C Administration on Erythropoietin Dosing Requirement in End-Stage Renal Disease Patients on Regular Hemodialysis
A study testing Normal regimen of treatment of anemia and Vitamin C in people with Vitamin C and Oral Administration, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin C, Oral Administration, Erythropoietin
- What is being tested?
- Normal regimen of treatment of anemia and Vitamin C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2019to 28 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Safety and Efficacy of 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.
Read the 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.
- Conditions
- Vitamin C, Oral Administration, Erythropoietin, End-Stage Renal Disease, Regular Hemodialysis
- Being tested
- Normal regimen of treatment of anemia, Vitamin C
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal regimen of treatment of anemiaDrug
Patients were on normal regimen of treatment of anemia.
Vitamin CDrug
Also called 250 mg oral vitamin C
Patients were on 250 mg oral vitamin C daily for 3 months.
Vitamin CDrug
Also called 500 mg oral vitamin C
Patients were on 500 mg oral vitamin C daily for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Patients were on normal regimen of treatment of anemia. Receives: Drug: Normal regimen of treatment of anemia |
| Group B | Experimental | Patients were on 250 mg oral vitamin C daily for 3 months. Receives: Drug: Vitamin C |
| Group C | Experimental | Patients were on 500 mg oral vitamin C daily for 3 months. Receives: Drug: Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin level
Hemoglobin level was assessed every month for 3 months
Measured: 3 months post-procedure
Secondary outcomes (3)
Serum iron level
Serum iron level was assessed every month for 3 months
Measured: 3 months post-procedure
Transferrin saturation
Transferrin saturation was assessed every month for 3 months
Measured: 3 months post-procedure
Change in erythropoietin dose
Change in erythropoietin dose was assessed every month for 3 months
Measured: 3 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2025
- Study start1 Aug 2019
- Primary completion28 Apr 2024
- Study completion28 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin CStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, marwa hassan, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076108
- Sponsor's protocol ID
- 252
- Status last verified
- Dec 2025
- First submitted
- 13 Jul 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Oral Vitamin C Administration on Erythropoietin Dosing Requirement in End-Stage Renal Disease Patients on Regular Hemodialysis
- ClinicalTrials.gov ID
- NCT07076108
- Acronym / sponsor ID
- 252
- Conditions
- Vitamin C, Oral Administration, Erythropoietin, End-Stage Renal Disease, Regular Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 28 Apr 2024 (actual)
- Study completion
- 28 Apr 2024 (actual)
- First posted
- 21 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Normal regimen of treatment of anemiaPatients were on normal regimen of treatment of anemia. |
| Group B | Experimental | Drug: Vitamin CPatients were on 250 mg oral vitamin C daily for 3 months. |
| Group C | Experimental | Drug: Vitamin CPatients were on 500 mg oral vitamin C daily for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal regimen of treatment of anemiaPatients were on normal regimen of treatment of anemia. | Drug | Group A |
| Vitamin CAlso: 250 mg oral vitamin CPatients were on 250 mg oral vitamin C daily for 3 months. | Drug | Group B |
| Vitamin CAlso: 500 mg oral vitamin CPatients were on 500 mg oral vitamin C daily for 3 months. | Drug | Group C |
Primary outcome
Hemoglobin level
Time frame: 3 months post-procedure
Hemoglobin level was assessed every month for 3 months
3 secondary outcomes
Serum iron level
Time frame: 3 months post-procedure
Transferrin saturation
Time frame: 3 months post-procedure
Change in erythropoietin dose
Time frame: 3 months post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal regimen of treatment of anemia and Vitamin C in people with Vitamin C and Oral Administration, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin level (time frame: 3 months post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.