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

NCT ID: NCT01001845

Last Updated: 2011-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-05-31

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.

Conditions

Hemodialysis; End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Lifestyle counseling

Group Type: NO_INTERVENTION

No interventions assigned to this group

vit E

200mg 2 times per day for 3 weeks

Group Type: ACTIVE_COMPARATOR

vit E

Intervention Type: DRUG

200 mg twice daily for 3 weeks

Milk Thistle extract

1 tablet (equivalent to 140 mg silymarin) 3 times a day for 3 weeks

Group Type: EXPERIMENTAL

Milk Thistle extract

Intervention Type: DRUG

1 tablet equivalent to 140 mg of silymarin, 3 times daily for 3 weeks

vit E + Milk Thistle Extract

200mg vit E twice a day + 1 tablet of Milk Thistle extract 3 times a day for 3 weeks

Group Type: EXPERIMENTAL

vit E + Milk Thistle extract

Intervention Type: DRUG

200 mg vit E twice daily + 1 tablet of Milk Thistle 3 times daily for 3 weeks

Interventions

Milk Thistle extract

1 tablet equivalent to 140 mg of silymarin, 3 times daily for 3 weeks

Intervention Type: DRUG

vit E

200 mg twice daily for 3 weeks

Intervention Type: DRUG

vit E + Milk Thistle extract

200 mg vit E twice daily + 1 tablet of Milk Thistle 3 times daily for 3 weeks

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shiraz University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Nephrology and Urology Research Center

Principal Investigators

Ghazal Vessal, PharmD, PhD

Role: STUDY_DIRECTOR

Shiraz University of Medical Sciences, Faculty of Pharmacy

Bahram Shahriari, MD

Role: PRINCIPAL_INVESTIGATOR

Shiraz University of Medical Sciences

Jamshid Roozbeh, MD

Role: STUDY_CHAIR

Nephrology Urology Research Center, Shiraz University of Medical Sciences

masoumeh Akmali, PhD

Role: PRINCIPAL_INVESTIGATOR

Shiraz University of Medical Sciences

Locations

Nemazi Hospital

Shiraz, Fars, Iran

Countries

Iran

Other Identifiers

53001

Identifier Type: -

Identifier Source: org_study_id