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NCT Number: NCT00920413

Oral Vitamin C for 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.

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases Peritoneal Dialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin C

Dietary Supplement

vitamin C 500mg orally once a day

Placebo

Dietary Supplement

Primary outcomes

  1. difference in percent change from baseline to 3 months in transferrin saturation between vitamin C and placebo

    Time frame: 3 months

Secondary outcomes

  1. difference in percent change from baseline to 3 months in hemoglobin,ferritin and epoetin dose (each determined separately)

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

Randomized, Double-Blind, Placebo-Controlled Trial of Oral Vitamin C on Correction of Anemia in Patients Receiving Peritoneal Dialysis

Important dates

Study start
2002
First posted
Jun 15, 2009
Registry last updated
Jun 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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