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

NCT ID: NCT02780505

Last Updated: 2016-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-06-30

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).

Detailed Description

World Health Organization (WHO) defines anemia as hemoglobin (Hgb) concentration less than 12.0 g/dL in pre-menopausal women, and lower than 13.0 g/dL in adult males and post-menopausal women .Diagnosis of anemia is of high significance, as it might be the first manifestation of a serious illness. Some chronic diseases which also can lead to anemia: autoimmune disorders, liver cirrhosis, cancer, and chronic renal disease Anemia is associated with poor prognosis of patients with chronic renal disease, especially those undergoing long-term hemodialysis. In patients with Glomerular filtration rate (GFR) less than 25 to 30 mL/min , anemia is observed within 90 percent of patients .

Among patients with chronic kidney disease (CKD), there is association between anemia and increased mortality secondary to cardiovascular diseases Ascorbic acid level is conflicted in under dialysis patients with different ranges of low, normal, and even above normal. In most hemodialysis patients, administration of 150 to 200 mg of vitamin C per day is recommended to maintain its levels. Ascorbic acid or vitamin C increases the delivery of iron from ferritin and the reticuloendothelial system and therefore elevates iron use during heme synthesis.

Vitamin deficiency is one of the cause of increased mortality among hemodialysis patients. During the dialysis process, vitamins are eliminated through hemodialyzer membranes, thus affect red blood cell production .Vitamin C deficiency may play an important role in increased inflammatory status of the dialysis patients . This vitamin has anti-inflammatory effects due to its electron transfer ability.

Several studies have shown the role of vitamins such as vitamin D and B12 in treatment of anemia in patients undergoing hemodialysis .The infusion of ascorbate supplementation might reduce oxidative stress. In addition, vitamin C plays an important role in iron metabolism and application in red blood cell formation . Permeable membrane is highly associated with a significant loss of vitamin C, and this vitamin improve oxidative stress in hemodialysis patients .

We aimed to assess the effect of vitamin C on patients with continuous ambulatory peritoneal dialysis (CAPD).

Conditions

Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

vitamin c

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.

Group Type: ACTIVE_COMPARATOR

vitamin c

Intervention Type: 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.

placebo

ُ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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: 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.

Interventions

vitamin c

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.

Intervention Type: DRUG

placebo

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.

Intervention Type: DRUG

Other Intervention Names

ascorbic acid

Eligibility Criteria

Inclusion Criteria

1. Long-term treatment of PD (at least more than three months)

2. Hemoglobin less than 15 milligrams per liter

3. Age over 18 years

4. vitamin c level less than 4microgram\ml

Exclusion Criteria

1. Acute illness (including infectious diseases and cancer) within 3 months prior to determining the level of vitamin C

2. Any recent blood transfusion, recurrent bleeding or hemolysis

3. Supplementation with vitamin C) during the 3 weeks prior to the determination of serum levels 4 -Consumption of tetracycline, antacid and Cholestyramine

5- diagnosis of primary hyperoxaloria

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shiraz University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Mohammad mahdi Sagheb

associate professor of internal medicine ,Nephrology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

zahra lotfi, fellowship

Role: PRINCIPAL_INVESTIGATOR

Shiraz University of Medical Sciences

Other Identifiers

CT905933

Identifier Type: -

Identifier Source: org_study_id