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Oral Vitamin C for Correction of Anemia in Patients Receiving Peritoneal Dialysis

This study has been completed.
Sponsor:
Information provided by:
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00920413
First received: June 12, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Anemia
Peritoneal Dialysis
Dietary Supplement: Vitamin C
Dietary Supplement: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled Trial of Oral Vitamin C on Correction of Anemia in Patients Receiving Peritoneal Dialysis

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • difference in percent change from baseline to 3 months in transferrin saturation between vitamin C and placebo [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • difference in percent change from baseline to 3 months in hemoglobin,ferritin and epoetin dose (each determined separately) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: March 2002
Arms Assigned Interventions
Active Comparator: vitamin C
vitamin C 500mg orally once a day
Dietary Supplement: Vitamin C
vitamin C 500mg orally once a day
Placebo Comparator: placebo Dietary Supplement: placebo

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00920413

Locations
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: Lori A MacCallum, PharmD St. Michael's Hospital, Toronto
  More Information

No publications provided

Responsible Party: Dr. Lori MacCallum, St. Michael's Hospital
ClinicalTrials.gov Identifier: NCT00920413     History of Changes
Other Study ID Numbers: 02-044
Study First Received: June 12, 2009
Last Updated: June 12, 2009
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Ascorbic Acid
Vitamins
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on November 27, 2014