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

Phase 2

Completed

• Conditions: Hemodialysis; End Stage Renal Disease
• Interventions: Drug: vit E; Drug: vit E + Milk Thistle extract; Drug: Milk Thistle extract

• Registration Number: NCT01001845
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-10-26
• Study First Submitted QC: 2009-10-26
• Study First Posted: 2009-10-27
• Primary Completion: 2010-03
• Study Completion: 2010-05
• Status Verified: 2010-09
• Last Update Submitted: 2011-01-21
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vit E	vit E	200mg 2 times per day for 3 weeks
vit E + Milk Thistle Extract	vit E + Milk Thistle extract	200mg vit E twice a day + 1 tablet of Milk Thistle extract 3 times a day for 3 weeks
Milk Thistle extract	Milk Thistle extract	1 tablet (equivalent to 140 mg silymarin) 3 times a day for 3 weeks

Primary Outcome Measures

Name	Time	Method
RBC Glutathion Peroxidase level	3 weeks

Secondary Outcome Measures

Name	Time	Method
Plasma malondialdehyde	3 weeks

Trial Locations

Locations (1)

Nemazi Hospital; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of