Effectiveness of Vitamin E as an add on with standard therapy and its effect on patients with chronic kidney disease on renal dialysis

Phase 3

Completed

Brief Summary: 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

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

Primary Outcome Measures

Name	Time	Method
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.	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.	At baseline, 4 weeks, 8 weeks and 12 weeks
The present investigation will also reveal the risk of morbidity and mortality among two groups.	At baseline, 4 weeks, 8 weeks and 12 weeks

Secondary Outcome Measures

Name	Time	Method
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

Locations (1): SRM Medical College Hospital and Research Centre
🇮🇳
Kancheepuram, TAMIL NADU, India
SRM Medical College Hospital and Research Centre
🇮🇳Kancheepuram, TAMIL NADU, India
Jagadeesan M
Principal investigator
7449277556
jagapharmd2013@gmail.com