Assessment of the Effect of Vitamin C on Anemia in Patients With Continuous Ambulatory Peritoneal Dialysi
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 66
- 主要终点
- level of vitamin c hemoglobin
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •5- diagnosis of primary hyperoxaloria
研究组 & 干预措施
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.
干预措施: vitamin c (Drug)
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
干预措施: placebo (Drug)
结局指标
主要结局
level of vitamin c hemoglobin
时间窗: six weeks prescription
次要结局
- c reactive protein(six weeks after prescription)
研究者
Mohammad mahdi Sagheb
associate professor of internal medicine ,Nephrology
Shiraz University of Medical Sciences