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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01001845
• Other study ID #: 53001
• Status: Completed
• Phase: Phase 2
• First received: October 26, 2009
• Last updated: January 21, 2011
• Start date: June 2009
• Est. completion date: May 2010

Study information

• Verified date: September 2010
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• End Stage Renal Disease
• Hemodialysis
• Kidney Failure, Chronic

Intervention

Drug:
• Milk Thistle extract
1 tablet equivalent to 140 mg of silymarin, 3 times daily for 3 weeks
• vit E
200 mg twice daily for 3 weeks
• vit E + Milk Thistle extract
200 mg vit E twice daily + 1 tablet of Milk Thistle 3 times daily for 3 weeks

Locations

Country	Name	City	State
Iran, Islamic Republic of	Nemazi Hospital	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RBC Glutathion Peroxidase level		3 weeks	No
Secondary	Plasma malondialdehyde		3 weeks	No