AnemiaPhase 3NCT00920413
Oral Vitamin C for Correction of Anemia in Patients Receiving Peritoneal Dialysis
A Phase 3 study testing Vitamin C in people with Anemia and Peritoneal Dialysis, run by Unity Health Toronto at 1 site in Canada.
Trial summary
People with kidney failure are at risk for the development of anemia. Anemia is a decrease in the production of hemoglobin, a substance that carries oxygen in the blood. The majority of patients require erythropoietin and iron supplementation to correct the anemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Peritoneal Dialysis
- What is being tested?
- Vitamin C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2002to not given
- Phase
- Phase 3
- 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
- Receiving peritoneal dialysis for 2 months
Who cannot join
- Red blood cell folate < 3.9 nmol/L
- Serum B12 <110 pmol/L
- Bleeding, blood transfusions, acute liver disease in the previous 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Trial of Oral Vitamin C on Correction of Anemia in Patients Receiving Peritoneal Dialysis
People with kidney failure are at risk for the development of anemia. Anemia is a decrease in the production of hemoglobin, a substance that carries oxygen in the blood. The majority of patients require erythropoietin and iron supplementation to correct the anemia. In some patients, the hemoglobin fails to rise to a desired level despite treatment with erythropoietin and iron. There have been several studies in hemodialysis patients showing that vitamin C given intravenously helps to correct anemia in patients already on erythropoietin and iron.
The purpose of this study is to determine whether oral vitamin C will improve parameters of anemia in patients receiving peritoneal dialysis.
Read more
Description of the research
This is a randomized, double blind, placebo controlled study. Participants will be randomized in a 1:1 ratio to oral vitamin C 500mg once a day or placebo for 3 months. All participants will be receiving oral iron supplementation, subcutaneous erythropoietin and a B and C complex vitamin containing 100mg of vitamin C. Lab parameters (hemoglobin, TSAT, ferritin) will be done at baseline and then monthly. The primary outcome is percent change from baseline in transferrin saturation. Secondary objectives are percent change in ferritin, hemoglobin and erythropoietin dose from baseline.
Read the detailed description
Patients will be randomized in a 1:1 ratio to Vitamin C 500mg orally once daily or matching placebo for 3 months. Randomization codes will be kept by the Research Pharmacy and investigators and patients will be blinded to treatment. Patients currently taking vitamin C supplements (excluding the 100mg of vitamin C contained in a B and C complex vitamin, a supplement used by all peritoneal dialysis patients), will be taken off the vitamin C and then randomized to one of the treatment arms after a 1 month washout period. At the end of 3 months, the effects of vitamin C on the change in transferrin saturation from baseline will be evaluated to identify which patients, if any, benefited from treatment. Hemoglobin, serum iron, total iron binding capacity, ferritin, transferrin saturation and erythropoietin dose will also be assessed. The dose and formulation of recombinant erythropoietin and oral iron will be adjusted during the study period according to standard practice algorithms currently used in the clinic. The addition of vitamin C does not pose any risk to the patients and will be dispensed to the patient by the Research Pharmacy at St. Michael's Hospital free of charge.
Patient population Inclusion criteria Receiving peritoneal dialysis for 2 months
Exclusion criteria Red blood cell folate < 3.9 nmol/L Serum B12 <110 pmol/L Bleeding, blood transfusions, acute liver disease in the previous 3 months
Assessments Parathyroid hormone Baseline B12 Baseline Folate Baseline Hemoglobin Baseline and monthly Hematocrit Baseline and monthly Ferritin Baseline and monthly Transferrin saturation Baseline and monthly Serum iron Baseline and monthly
- Conditions
- Anemia, Peritoneal Dialysis
- Being tested
- Vitamin C, placebo
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDietary supplement
vitamin C 500mg orally once a day
placeboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| vitamin C | Active comparator | vitamin C 500mg orally once a day Receives: Dietary Supplement: Vitamin C |
| placebo | Placebo comparator | Not described Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in percent change from baseline to 3 months in transferrin saturation between vitamin C and placebo
Measured: 3 months
Secondary outcomes (1)
difference in percent change from baseline to 3 months in hemoglobin,ferritin and epoetin dose (each determined separately)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2009 (estimated)
- Study startMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Lori A MacCallum, PharmD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00920413
- Sponsor's protocol ID
- 02-044
- Status last verified
- Jun 2009
- First submitted
- 12 Jun 2009
- Last updated
- 15 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Trial of Oral Vitamin C on Correction of Anemia in Patients Receiving Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT00920413
- Acronym / sponsor ID
- 02-044
- Conditions
- Anemia, Peritoneal Dialysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Mar 2002
- First posted
- 15 Jun 2009 (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.
People with kidney failure are at risk for the development of anemia. Anemia is a decrease in the production of hemoglobin, a substance that carries oxygen in the blood. The majority of patients require erythropoietin and iron supplementation to correct the anemia. In some patients, the hemoglobin fails to rise to a desired level despite treatment with erythropoietin and iron. There have been several studies in hemodialysis patients showing that vitamin C given intravenously helps to correct anemia in patients already on erythropoietin and iron.
The purpose of this study is to determine whether oral vitamin C will improve parameters of anemia in patients receiving peritoneal dialysis.
Description of the research
This is a randomized, double blind, placebo controlled study. Participants will be randomized in a 1:1 ratio to oral vitamin C 500mg once a day or placebo for 3 months. All participants will be receiving oral iron supplementation, subcutaneous erythropoietin and a B and C complex vitamin containing 100mg of vitamin C. Lab parameters (hemoglobin, TSAT, ferritin) will be done at baseline and then monthly. The primary outcome is percent change from baseline in transferrin saturation. Secondary objectives are percent change in ferritin, hemoglobin and erythropoietin dose from baseline.
Detailed description
Patients will be randomized in a 1:1 ratio to Vitamin C 500mg orally once daily or matching placebo for 3 months. Randomization codes will be kept by the Research Pharmacy and investigators and patients will be blinded to treatment. Patients currently taking vitamin C supplements (excluding the 100mg of vitamin C contained in a B and C complex vitamin, a supplement used by all peritoneal dialysis patients), will be taken off the vitamin C and then randomized to one of the treatment arms after a 1 month washout period. At the end of 3 months, the effects of vitamin C on the change in transferrin saturation from baseline will be evaluated to identify which patients, if any, benefited from treatment. Hemoglobin, serum iron, total iron binding capacity, ferritin, transferrin saturation and erythropoietin dose will also be assessed. The dose and formulation of recombinant erythropoietin and oral iron will be adjusted during the study period according to standard practice algorithms currently used in the clinic. The addition of vitamin C does not pose any risk to the patients and will be dispensed to the patient by the Research Pharmacy at St. Michael's Hospital free of charge.
Patient population Inclusion criteria Receiving peritoneal dialysis for 2 months
Exclusion criteria Red blood cell folate < 3.9 nmol/L Serum B12 <110 pmol/L Bleeding, blood transfusions, acute liver disease in the previous 3 months
Assessments Parathyroid hormone Baseline B12 Baseline Folate Baseline Hemoglobin Baseline and monthly Hematocrit Baseline and monthly Ferritin Baseline and monthly Transferrin saturation Baseline and monthly Serum iron Baseline and monthly
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin C | Active comparator | Dietary Supplement: Vitamin Cvitamin C 500mg orally once a day |
| placebo | Placebo comparator | Dietary Supplement: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Receiving peritoneal dialysis for 2 months
Key exclusion criteria (3 listed)
- Red blood cell folate < 3.9 nmol/L
- Serum B12 <110 pmol/L
- Bleeding, blood transfusions, acute liver disease in the previous 3 months
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 |
|---|---|---|
| Vitamin Cvitamin C 500mg orally once a day | Dietary supplement | vitamin C |
| placebo | Dietary supplement | placebo |
Primary outcome
difference in percent change from baseline to 3 months in transferrin saturation between vitamin C and placebo
Time frame: 3 months
1 secondary outcome
difference in percent change from baseline to 3 months in hemoglobin,ferritin and epoetin dose (each determined separately)
Time frame: 3 months
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 15 Jun 2009.
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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.
Lori A MacCallum, PharmD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin C in people with Anemia and Peritoneal Dialysis, run by Unity Health Toronto at 1 site in Canada.
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 1 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 15 Jun 2009. 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 Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
difference in percent change from baseline to 3 months in transferrin saturation between vitamin C and placebo (time frame: 3 months). 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 15 Jun 2009.