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

NCT00920413 | Completed Phase 3

• 1 other identifier: 02-044
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Anemia; Peritoneal Dialysis

Outcome Measures

Primary Outcomes (1)

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

  3 months

Secondary Outcomes (1)

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

  3 months

Study Arms (2)

vitamin C

ACTIVE COMPARATOR

vitamin C 500mg orally once a day

Dietary Supplement: Vitamin C

placebo

PLACEBO COMPARATOR

Dietary Supplement: placebo

Interventions

Vitamin C DIETARY_SUPPLEMENT

vitamin C 500mg orally once a day

vitamin C

placebo DIETARY_SUPPLEMENT

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Receiving peritoneal dialysis for 2 months

You may not qualify if:

• Red blood cell folate \< 3.9 nmol/L
• Serum B12 \<110 pmol/L
• Bleeding, blood transfusions, acute liver disease in the previous 3 months

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

Anemia

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Lori A MacCallum, PharmD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 12, 2009
• First Posted: June 15, 2009
• Study Start: March 1, 2002
• Last Updated: June 15, 2009

Record last verified: 2009-06

Locations

CA (1)