Anaemia Response to the TreatmentPhase 4FeVitCNCT02225886
Ascorbic Acid Administration in the Treatment of Anemia in Chronic Hemodialysed Patients
A Phase 4 study testing Ascorbic Acid in people with Anaemia Response to the Treatment and Peripheral Iron Indices, run by Anemia Working Group Romania at 1 site in Romania.
Trial summary
The administration of ascorbic acid seemed to increase the iron available for erythropoiesis, thus improving the anemia response to the treatment. The investigators therefore aimed to evaluate the effects of intravenous ascorbic acid administration in hemodialysed patients with iron overload. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Anaemia Response to the Treatment, Peripheral Iron Indices, Oxalemia
- What is being tested?
- Ascorbic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteRomania
- Study dates
- 1 Feb 2020to Dec 2023
- Phase
- Phase 4
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18 years old
- At least 6 months on hemodialysis at the time of randomization;
- Kt/V≥1.2;
- average of the last three serum ferritin levels > 500 ng/mL AND
- Average of the last three TSAT levels > 20% and increasing
- ERI in the 4th quartile of the group
Who cannot join
- Active bleeding or other cause of anemia
- Serum level of intact parathyroid hormone (iPTH)>800 pg/mL
- Actual neoplasia
- HIV, Hepatitis B or C infections
- Significant inflammation (CRP>12mg/L) or acute infection
- Venous central catheter
Show all 10Show fewer
- Severe hepatic, cardiovascular, psychic disease or other severe comorbidities
- Moderate or severe malnutrition
- Blood transfusions in the 2 months prior to screening
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
"Nefrolab" Dialysis Center
Slatina
Aurelian Simionescu, MD, PhD, +40732161768, relusimionescu@yahoo.com
Ileana Mihailescu, MD, +40730577485, dr_ilemih@yahoo.com
About this study
Official title: Effects of Ascorbic Acid Administration in the Treatment of Anemia in Chronic Hemodialysed Patients With Iron Overload
The administration of ascorbic acid seemed to increase the iron available for erythropoiesis, thus improving the anemia response to the treatment.
The investigators therefore aimed to evaluate the effects of intravenous ascorbic acid administration in hemodialysed patients with iron overload.
Read the detailed description
Renal anemia is a complex condition in which chronic inflammation, among other factors, can change the iron distribution by locking it in deposits, and also, iron metabolism parameters. Thus, is hard to separate the iron functional deficit from overload.
The ascorbic acid is a hydrosoluble vitamin capable of reduction and hydrolysis. As a reduction agent, the ascorbic acid supports the transformation of ferric iron to ferrous iron. For instance, the ascorbic acid can increase digestive absorption and taking over the iron without transferrin, helps iron release from ferritin and hemosiderin and delays ferritin conversion to hemosiderin; therefore, the administration of ascorbic acid can increase the quantity of iron available for erythropoiesis by realising it from the deposits.
Consequently, the antioxidant function of ascorbic acid can increase the red cells' lifetime, reducing the inflammation and improving erythropoietin response Following these premises, recent studies have examined the effect of administrating ascorbic acid to hemodialysed patients with erythropoiesis stimulating agents (ESA) hyporesponsiveness anemia and functional deficit or iron overload markers. The results of administering ascorbic acid revealed an increased level of hemoglobin and transferrin saturation (TSAT) combined with the decrease of ESA doses. The major limitations of these studies are the short amount of time for observation (<6months) and the limited number of participants which hampered neither the complete evaluation of the goals, nor the adverse effects of supplementary administration of vitamin C.
Until now, the Clinical practice guidelines of Kidney Disease do not recommend currently using of high doses of vitamin C, considering the risk of a high level of oxalemia and the limited information about the benefits. Considering this background, we intended to evaluate the benefits of intravenous administration of ascorbic acid in hemodialysed patients with iron balance markers suggestive for iron overload.
- Being tested
- Ascorbic Acid
- Keywords
- Renal anaemia, Intravenous ascorbic acid, Intravenous iron administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic AcidDrug
300 mg of intravenous ascorbic acid will be given 3 times a week, postdialysis, in 100 mL saline solution, except for the dialysis sessions when iv iron is administered
| Study group | Role | What they receive |
|---|---|---|
| Ascorbic acid | Experimental | Patients will receive a 300 mg intravenous ascorbic acid, 3 times a week, postdialysis, except for the dialysis sessions when iv iron is administered. Receives: Drug: Ascorbic Acid |
| Control group | Placebo comparator | Patients will receive 100 mL saline solution, 3 times a week, with associated medication, except but the dialysis sessions when iv iron is administered. Receives: Drug: Ascorbic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of erythropoetin resistance index (ERI)
Erythropoietin resistance index: the dose of ESA divided by the level of Hb - will be calculated monthly.
Measured: 12 months
Secondary outcomes (11)
Percentage of patients with Hb in the target range
Percentage of patients with stable the hemoglobin in the target range (10.5-12g/dL), without any change in the weekly dose of ESA
Measured: 12 months
Changes in ESA dose
The number of reductions or increases in the ESA dose during the study
Measured: 12 months
Variation in ESA dose
The difference between the actual ESA dose and the one at baseline will be calculated monthly.
Measured: 12 months
Variation of iron dose
The difference between the actual iron dose and the one at baseline will be calculated monthly.
Measured: 12 months
Percentage of patients with hemoglobin within target
Percentage of patients with 10<Hb<12.1 g/dL will be calculated monthly.
Measured: 12 months
Percentage of patients with target iron status
Percentage of patients with 100<serum ferritin<800 ng/mL and 19<transferrin saturation<51% will be calculated monthly.
Measured: 12 months
Variation of serum hepcidin
Variation of serum hepcidin will be calculated every 3 months
Measured: 12 months
Oxalemia
Serum oxalate level will be calculated every 3 months
Measured: 12 months
Local and general tolerance to vitamin C
Local and general tolerance to vitamin C will be evaluated monthly
Measured: 12 months
Adverse events
Adverse events will be evaluated monthly
Measured: 12 months
The number of withdrawals and dropouts
The number of withdrawals and dropouts will be calculated monthly
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study start1 Feb 2020
- Primary completionMar 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anaemia Response to the TreatmentStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anemia Working Group Romania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriel Mircescu, Professor, Study chair, Anemia Working Group RomaniaLiliana Garneata, MD, PhD, Study director, Anemia Workiing Group RomaniaTudor Simionescu, MD, PhD, Principal investigator, "Carol Davila" Teaching Hospital of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225886
- Sponsor's protocol ID
- AWGRO 06/2014
- Acronym
- FeVitC
- Status last verified
- Feb 2020
- First submitted
- 23 Aug 2014
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication
Publications
Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.
PubMed 37916745
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ascorbic Acid Administration in the Treatment of Anemia in Chronic Hemodialysed Patients With Iron Overload
- ClinicalTrials.gov ID
- NCT02225886
- Acronym / sponsor ID
- FeVitC / AWGRO 06/2014
- Keywords
- Renal anaemia, Intravenous ascorbic acid, Intravenous iron administration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Anemia Working Group RomaniaUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 26 Aug 2014 (estimated)
- 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 administration of ascorbic acid seemed to increase the iron available for erythropoiesis, thus improving the anemia response to the treatment.
The investigators therefore aimed to evaluate the effects of intravenous ascorbic acid administration in hemodialysed patients with iron overload.
Detailed description
Renal anemia is a complex condition in which chronic inflammation, among other factors, can change the iron distribution by locking it in deposits, and also, iron metabolism parameters. Thus, is hard to separate the iron functional deficit from overload.
The ascorbic acid is a hydrosoluble vitamin capable of reduction and hydrolysis. As a reduction agent, the ascorbic acid supports the transformation of ferric iron to ferrous iron. For instance, the ascorbic acid can increase digestive absorption and taking over the iron without transferrin, helps iron release from ferritin and hemosiderin and delays ferritin conversion to hemosiderin; therefore, the administration of ascorbic acid can increase the quantity of iron available for erythropoiesis by realising it from the deposits.
Consequently, the antioxidant function of ascorbic acid can increase the red cells' lifetime, reducing the inflammation and improving erythropoietin response Following these premises, recent studies have examined the effect of administrating ascorbic acid to hemodialysed patients with erythropoiesis stimulating agents (ESA) hyporesponsiveness anemia and functional deficit or iron overload markers. The results of administering ascorbic acid revealed an increased level of hemoglobin and transferrin saturation (TSAT) combined with the decrease of ESA doses. The major limitations of these studies are the short amount of time for observation (<6months) and the limited number of participants which hampered neither the complete evaluation of the goals, nor the adverse effects of supplementary administration of vitamin C.
Until now, the Clinical practice guidelines of Kidney Disease do not recommend currently using of high doses of vitamin C, considering the risk of a high level of oxalemia and the limited information about the benefits. Considering this background, we intended to evaluate the benefits of intravenous administration of ascorbic acid in hemodialysed patients with iron balance markers suggestive for iron overload.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ascorbic acid | Experimental | Drug: Ascorbic AcidPatients will receive a 300 mg intravenous ascorbic acid, 3 times a week, postdialysis, except for the dialysis sessions when iv iron is administered. |
| Control group | Placebo comparator | Drug: Ascorbic AcidPatients will receive 100 mL saline solution, 3 times a week, with associated medication, except but the dialysis sessions when iv iron is administered. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age above 18 years old
- At least 6 months on hemodialysis at the time of randomization;
- Kt/V≥1.2;
- average of the last three serum ferritin levels > 500 ng/mL AND
- Average of the last three TSAT levels > 20% and increasing
Key exclusion criteria (10 listed)
- Active bleeding or other cause of anemia
- Serum level of intact parathyroid hormone (iPTH)>800 pg/mL
- Actual neoplasia
- HIV, Hepatitis B or C infections
- Significant inflammation (CRP>12mg/L) or acute infection
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 |
|---|---|---|
| Ascorbic Acid300 mg of intravenous ascorbic acid will be given 3 times a week, postdialysis, in 100 mL saline solution, except for the dialysis sessions when iv iron is administered | Drug | Ascorbic acid, Control group |
Primary outcome
Variation of erythropoetin resistance index (ERI)
Time frame: 12 months
Erythropoietin resistance index: the dose of ESA divided by the level of Hb - will be calculated monthly.
11 secondary outcomes
Percentage of patients with Hb in the target range
Time frame: 12 months
Changes in ESA dose
Time frame: 12 months
Variation in ESA dose
Time frame: 12 months
Variation of iron dose
Time frame: 12 months
Percentage of patients with hemoglobin within target
Time frame: 12 months
Percentage of patients with target iron status
Time frame: 12 months
Variation of serum hepcidin
Time frame: 12 months
Oxalemia
Time frame: 12 months
Local and general tolerance to vitamin C
Time frame: 12 months
Adverse events
Time frame: 12 months
The number of withdrawals and dropouts
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Derived from this study: PubMed 37916745Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.
- Individual participant dataSharing planned: Yes. Publication
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Active, not recruitingPhase 4
A Study to Evaluate the Safety and Effectiveness of Luspatercept for the Treatment of Transfusion-dependent (TD) Anemia Associated With Myelodysplastic Syndromes (MDS) & Beta-thalassemia (β-Thal) in India
Anemia
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.
Gabriel Mircescu, Professor study chair
Anemia Working Group Romania
Liliana Garneata, MD, PhD study director
Anemia Workiing Group Romania
Tudor Simionescu, MD, PhD principal investigator
"Carol Davila" Teaching Hospital of Nephrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ascorbic Acid in people with Anaemia Response to the Treatment and Peripheral Iron Indices, run by Anemia Working Group Romania at 1 site in Romania.
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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 24 Feb 2020. 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 Romania. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liliana Garneata, MD, PhD (+40722619358, liliana.garneata@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of erythropoetin resistance index (ERI) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02225886, which also lists 1 linked publication.
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 24 Feb 2020.