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

NCT01001845 | Completed Phase 2 DMC

• 1 other identifier: 53001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

hemodialysis; oxidative stress; plasma malondialdehyde; Glutathion peroxidase

Outcome Measures

Primary Outcomes (1)

• RBC Glutathion Peroxidase level

  3 weeks

Secondary Outcomes (1)

• Plasma malondialdehyde

  3 weeks

Study Arms (4)

Lifestyle counseling

NO INTERVENTION

vit E

ACTIVE COMPARATOR

200mg 2 times per day for 3 weeks

Drug: vit E

Milk Thistle extract

EXPERIMENTAL

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

Drug: Milk Thistle extract

vit E + Milk Thistle Extract

EXPERIMENTAL

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

Interventions

Milk Thistle extract DRUG

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

Milk Thistle extract

vit E DRUG

200 mg twice daily for 3 weeks

vit E

vit E + Milk Thistle extract DRUG

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

vit E + Milk Thistle Extract

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (1)

Nemazi Hospital

Shiraz, Fars, 71345, Iran

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

milk-thistle extract

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ghazal Vessal, PharmD, PhD

  Shiraz University of Medical Sciences, Faculty of Pharmacy

  STUDY DIRECTOR

• Bahram Shahriari, MD

  Shiraz University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Jamshid Roozbeh, MD

  Nephrology Urology Research Center, Shiraz University of Medical Sciences

  STUDY CHAIR

• masoumeh Akmali, PhD

  Shiraz University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 26, 2009
• First Posted: October 27, 2009
• Study Start: June 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: May 1, 2010
• Last Updated: January 24, 2011

Record last verified: 2010-09

Locations

IR (1)