Evaluation of Vitamin E as an add on with standard therapy and its effect on plasma Pentraxin-3 in patients with chronic kidney disease on renal dialysis A Randomized control Clinical Trail
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The outcome will also determine whether the extent of tissue injury (marked by the serum concentration of PTX-3) has any significant change between two groups.
研究概览
简要总结
Chronic kidney disease (CKD) is associated with increased cardiovascular morbidity and mortality even in the early stages of the disease patients on hemodialysis have limited life expectancy due to multiple co-morbidities and complications due to internal injury and inflammation. Many studies have proven that serum/plasma pentraxin 3 is the sensitive biomarker for internal injury and inflammation than the hsCRP. In dialysis patients, oxidative stress and inflammation are associated with the development of CVD. The pro-inflammatory/anti-inflammatory phenotype is disturbed on the pro-inflammatory side in CKD patients. The oxygen-free radicals are central to the pathology of many degenerative diseases, including those of the kidney. Enhanced oxygen radical generation and/or a compromized antioxidant defence system results in chronic oxidative stress which significantly worsens many conditions includes cardiovascular diseases. Preservation of glomerular membrane integrity is crucial to renal function and biological membranes are protected from oxidative deterioration by the lipophilic antioxidant vitamin E, principally in the form of a-tocopherol. Vitamin E has potent antiinflammatory and anticoagulant properties. Additionally, it can prevent apoptosis due to oxidative stress. Therefore this study aimed to investigate the antioxidants as an add on with usual/regular therapy and its effect on plasma Pentraxin-3 in CKD patients with renal dialysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either gender, suffering from chronic kidney disease on hemodialysis at least for 3 months and age of 40 years to 70 years.
- •CKD patients on haemodialysis who were able to understand and agree for informed written informed consent for the participation in this study.
- •CKD patients on haemodialysis with Diabetes mellitus and hypertension as co-morbidities.
排除标准
- •CKD patients on haemodialysis who were disable or immobile.
- •CKD patients on haemodialysis with associated chronic liver disease (CLD), congestive heart failure (CHF), HIV, Active tuberculosis.
- •CKD patients on haemodialysis with immunosuppressive therapy and clinical signs of ongoing infection.
- •CKD patients with haemodialysis not on antioxidant therapy for last 3-6 months.
结局指标
主要结局
The outcome will also determine whether the extent of tissue injury (marked by the serum concentration of PTX-3) has any significant change between two groups.
时间窗: At baseline, 4 weeks, 8 weeks and 12 weeks
The outcome of this study will help us to understand the significance of measuring serum PTX-3 levels among CKD patients on dialysis.
时间窗: At baseline, 4 weeks, 8 weeks and 12 weeks
The present investigation will also reveal the risk of morbidity and mortality among two groups.
时间窗: At baseline, 4 weeks, 8 weeks and 12 weeks
次要结局
- Impact of Anti-oxidents in CKD patients on dialysis will be determined by serum pentroxin-3 level(At baseline, 4 weeks, 8 weeks and 12 weeks)