Clinical trial NCT02780505: Assessment of the Effect of Vitamin C on Anemia in Patients With Continuous Ambulatory Peritoneal Dialysis
Official title: Assessment of the Effect of Vitamin C on Anemia in Patients With Continuous Ambulatory Peritoneal Dialysi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-05-23
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: level of vitamin c hemoglobin
timeFrame: six weeks prescription
Secondary outcomes:
measure: c reactive protein
timeFrame: six weeks after prescription
Other outcomes:
Locations:
Study officials:
affiliation: Shiraz University of Medical Sciences
name: zahra lotfi, fellowship
role: PRINCIPAL_INVESTIGATOR
References: