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

January 21, 2011 updated by: Shiraz University of Medical Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
RBC Glutathion Peroxidase level
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma malondialdehyde
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiraz University of Medical Sciences

Investigators

  • Study Director: Ghazal Vessal, PharmD, PhD, Shiraz University of Medical Sciences, Faculty of Pharmacy
  • Principal Investigator: Bahram Shahriari, MD, shiraz University of medical sciences
  • Study Chair: Jamshid Roozbeh, MD, Nephrology Urology Research Center, Shiraz University of Medical Sciences
  • Principal Investigator: masoumeh Akmali, PhD, shiraz University of medical sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

October 26, 2009

First Submitted That Met QC Criteria

October 26, 2009

First Posted (Estimate)

October 27, 2009

Study Record Updates

Last Update Posted (Estimate)

January 24, 2011

Last Update Submitted That Met QC Criteria

January 21, 2011

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 53001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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