Comparative Effects of Milk Thistle Extract With Vitamin-E in Hemodialysis Patients

Study Overview
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Brief Summary
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For end-stage renal disease (ESRD) patients, cardiovascular disease remains the single most common cause of excess morbidity and mortality. Among the examined nontraditional risk factors, an increase in oxidative stress as well as inflammation are postulated to contribute to excessive cardiovascular risk in this population. Flavonoids are naturally occurring substances that possess various pharmacological actions and therapeutic applications. Some due to their phenolic structures have antioxidant effect and inhibit free radical-mediated processes, as well as anti-inflammatory effects. Silymarin,a mixture of three isomeric flavonolignans, is isolated from milk thistle (Silybum marianum) seeds, and is proven to have anti-oxidant, anti-inflammatory, cell regenerating, and antifibrotic action. In this study, the effect of silymarin on oxidative stress and inflammation (2 major risk factors for cardiovascular morbidity and mortality in hemodialysis patients)is evaluated, and compared to vit E, a well known antioxidant.

Official Title
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Comparative Effects of Milk Thistle Extract With Vitamin-E on Oxidative Stress Biomarkers in Hemodialysis Patients

Conditions
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Hemodialysis, End Stage Renal Disease

Intervention / Treatment
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* Drug: Milk Thistle extract
* Drug: vit E
* Drug: vit E + Milk Thistle extract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All hemodialysis patients age 18-60 On hemodialysis for over 3 months, 3 times a week, and for 4 hours each time Signed informed consent Exclusion Criteria: Heart Failure NYHA Class III or IV Recent MI (within 1 year) Use of anti-oxidant supplements: N-acetyl-cystein, Omega 3, Vit C, Vit E, green tea, soy extracts, pomegranate extract, grape extract.. Hepatitis B or C Active Infection Psychiatric illness Active malignancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Lifestyle counseling<br> | |
| Active Comparator: vit E<br>200mg 2 times per day for 3 weeks | Drug: vit E<br>* 200 mg twice daily for 3 weeks<br>|
| Experimental: Milk Thistle extract<br>1 tablet (equivalent to 140 mg silymarin) 3 times a day for 3 weeks | Drug: Milk Thistle extract<br>* 1 tablet equivalent to 140 mg of silymarin, 3 times daily for 3 weeks<br>|
| Experimental: vit E + Milk Thistle Extract<br>200mg vit E twice a day + 1 tablet of Milk Thistle extract 3 times a day for 3 weeks | Drug: vit E + Milk Thistle extract<br>* 200 mg vit E twice daily + 1 tablet of Milk Thistle 3 times daily for 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RBC Glutathion Peroxidase level |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma malondialdehyde |  | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis, oxidative stress, plasma malondialdehyde, Glutathion peroxidase