Assessment of the Effect of Vitamin C on Anemia in Patients With Continuous Ambulatory Peritoneal Dialysis

NCT02780505 | Completed Phase 4

• 1 other identifier: CT905933
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief Summary

Among patients with chronic kidney disease (CKD), there is association between anemia and increased chance of mortality mainly because of cardiovascular diseases and stroke, risk of hospitalization, and death prevalence in predialysis patients. Vitamin C plays an important role in iron metabolism and application for red blood cell formation. Infusion of ascorbate supplementation can reduce oxidative stress among hemodialysis patients. This study aimed to assess the effect of vitamin C on patients with continuous ambulatory peritoneal dialysis (CAPD).

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• level of vitamin c hemoglobin

  six weeks prescription

Secondary Outcomes (1)

• c reactive protein

  six weeks after prescription

Study Arms (2)

vitamin c

ACTIVE COMPARATOR

vitamin C supplement orally up to 250 mg per day for 6 weeks was prescribed. Plasma levels of vitamin C and other clinical parameters including hemoglobin, ferritin, TIBC, iron and CRP were measured at the beginning and end of the study.

Drug: vitamin c

placebo

PLACEBO COMPARATOR

ُPlacebo prescribed to Group B. Plasma levels of vitamin C and other clinical parameters including hemoglobin, ferritin, TIBC, iron and CRP were measured at the beginning and end of the study

Drug: placebo

Interventions

vitamin c DRUG

In the current prospective, double-blind, and randomized trial, 66 patients with peritoneal dialysis were enrolled, and 43 patients were detected with serum vitamin C level below 4 μg/ml to determine the effect of vit C on anemia in patients on CAPD. The measured clinical parameters including plasma vitamin C level, hemoglobin (Hb), Ferritin, total iron-binding capacity (TIBC), serum Fe, C-reactive protein (CRP), and transferrin saturation. Consumption of vitamin supplements such as vitamin C (or any other form of it) either oral or parenteral were discontinued three weeks before collecting the samples.

Also known as: ascorbic acid

vitamin c

placebo DRUG

Active (ascorbic acid 250 mg) and placebo (same weight of starch) tablets were similar in shape and size for both study and control groups. Intravenous intervention was not advantageous for hemodialysis subjects and it was impossible for PD patients, therefore, oral administration was used. All follow-up records were stored. The erythropoietin (EPO) injections was prescribed for each patient in weekly dose, started one month before collecting blood samples for vitamin C measurement.

placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Long-term treatment of PD (at least more than three months)
• Hemoglobin less than 15 milligrams per liter
• Age over 18 years
• vitamin c level less than 4microgram\\ml

You may not qualify if:

• Acute illness (including infectious diseases and cancer) within 3 months prior to determining the level of vitamin C
• Any recent blood transfusion, recurrent bleeding or hemolysis
• Supplementation with vitamin C) during the 3 weeks prior to the determination of serum levels 4 -Consumption of tetracycline, antacid and Cholestyramine
• diagnosis of primary hyperoxaloria

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

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

• zahra lotfi, fellowship

  Shiraz University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor of internal medicine ,Nephrology

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: May 23, 2016
• Study Start: November 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 23, 2016

Record last verified: 2016-05