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

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ClinicalTrials.gov Identifier: NCT02780505
Recruitment Status : Completed
First Posted : May 23, 2016
Last Update Posted : May 23, 2016
Sponsor:
Information provided by (Responsible Party):
Mohammad mahdi Sagheb, Shiraz University of Medical Sciences

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).

Condition or disease Intervention/treatment Phase
Anemia Drug: vitamin c Drug: placebo Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of the Effect of Vitamin C on Anemia in Patients With Continuous Ambulatory Peritoneal Dialysi
Study Start Date : November 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Vitamin C

Arm Intervention/treatment
Active Comparator: 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.
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.

Other Name: ascorbic acid

Placebo Comparator: 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
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.





Primary Outcome Measures :
  1. level of vitamin c hemoglobin [ Time Frame: six weeks prescription ]

Secondary Outcome Measures :
  1. c reactive protein [ Time Frame: six weeks after prescription ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02780505


Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
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Principal Investigator: zahra lotfi, fellowship Shiraz University of Medical Sciences
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Responsible Party: Mohammad mahdi Sagheb, associate professor of internal medicine ,Nephrology, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02780505    
Other Study ID Numbers: CT905933
First Posted: May 23, 2016    Key Record Dates
Last Update Posted: May 23, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases
Ascorbic Acid
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents