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

This study has been completed.
Sponsor:
Information provided by:
Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01001845
First received: October 26, 2009
Last updated: January 21, 2011
Last verified: September 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Hemodialysis
End Stage Renal Disease
 Drug: Milk Thistle extract
Drug: vit E
Drug: vit E + Milk Thistle extract
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Comparative Effects of Milk Thistle Extract With Vitamin-E on Oxidative Stress Biomarkers in Hemodialysis Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • RBC Glutathion Peroxidase level [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma malondialdehyde [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: June 2009
Study Completion Date: May 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001845

Locations
Iran, Islamic Republic of
Nemazi Hospital
Shiraz, Fars, Iran, Islamic Republic of, 71345
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Dr. Jamshid Roozbeh, Nephrology and Urology Research Center
ClinicalTrials.gov Identifier: NCT01001845     History of Changes
Other Study ID Numbers: 53001
Study First Received: October 26, 2009
Last Updated: January 21, 2011
Health Authority: Iran: Ethics Committee

Keywords provided by Shiraz University of Medical Sciences:
hemodialysis
oxidative stress
plasma malondialdehyde
Glutathion peroxidase

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Vitamin E
Alpha-Tocopherol
Tocopherols
 Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013