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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02780505
• Other study ID #: CT905933
• Status: Completed
• Phase: Phase 4
• First received: May 18, 2016
• Last updated: May 19, 2016
• Start date: November 2011
• Est. completion date: June 2012

Study information

• Verified date: May 2016
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	level of vitamin c hemoglobin		six weeks prescription	No
Secondary	c reactive protein		six weeks after prescription	Yes