Comparative Effects of Milk Thistle Extract With Vitamin-E in Hemodialysis Patients
Primary Purpose
Hemodialysis, End Stage Renal Disease
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Milk Thistle extract
vit E
vit E + Milk Thistle extract
Sponsored by
About this trial
This is an interventional prevention trial for Hemodialysis focused on measuring hemodialysis, oxidative stress, plasma malondialdehyde, Glutathion peroxidase
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
Sites / Locations
- Nemazi Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Active Comparator
Experimental
Experimental
Arm Label
Lifestyle counseling
vit E
Milk Thistle extract
vit E + Milk Thistle Extract
Arm Description
200mg 2 times per day for 3 weeks
1 tablet (equivalent to 140 mg silymarin) 3 times a day for 3 weeks
200mg vit E twice a day + 1 tablet of Milk Thistle extract 3 times a day for 3 weeks
Outcomes
Primary Outcome Measures
RBC Glutathion Peroxidase level
Secondary Outcome Measures
Plasma malondialdehyde
Full Information
NCT ID
NCT01001845
First Posted
October 26, 2009
Last Updated
January 21, 2011
Sponsor
Shiraz University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01001845
Brief Title
Comparative Effects of Milk Thistle Extract With Vitamin-E in Hemodialysis Patients
Official Title
Comparative Effects of Milk Thistle Extract With Vitamin-E on Oxidative Stress Biomarkers in Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shiraz University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis, End Stage Renal Disease
Keywords
hemodialysis, oxidative stress, plasma malondialdehyde, Glutathion peroxidase
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle counseling
Arm Type
No Intervention
Arm Title
vit E
Arm Type
Active Comparator
Arm Description
200mg 2 times per day for 3 weeks
Arm Title
Milk Thistle extract
Arm Type
Experimental
Arm Description
1 tablet (equivalent to 140 mg silymarin) 3 times a day for 3 weeks
Arm Title
vit E + Milk Thistle Extract
Arm Type
Experimental
Arm Description
200mg vit E twice a day + 1 tablet of Milk Thistle extract 3 times a day for 3 weeks
Intervention Type
Drug
Intervention Name(s)
Milk Thistle extract
Intervention Description
1 tablet equivalent to 140 mg of silymarin, 3 times daily for 3 weeks
Intervention Type
Drug
Intervention Name(s)
vit E
Intervention Description
200 mg twice daily for 3 weeks
Intervention Type
Drug
Intervention Name(s)
vit E + Milk Thistle extract
Intervention Description
200 mg vit E twice daily + 1 tablet of Milk Thistle 3 times daily for 3 weeks
Primary Outcome Measure Information:
Title
RBC Glutathion Peroxidase level
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Plasma malondialdehyde
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghazal Vessal, PharmD, PhD
Organizational Affiliation
Shiraz University of Medical Sciences, Faculty of Pharmacy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bahram Shahriari, MD
Organizational Affiliation
Shiraz University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jamshid Roozbeh, MD
Organizational Affiliation
Nephrology Urology Research Center, Shiraz University of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
masoumeh Akmali, PhD
Organizational Affiliation
Shiraz University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nemazi Hospital
City
Shiraz
State/Province
Fars
ZIP/Postal Code
71345
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Comparative Effects of Milk Thistle Extract With Vitamin-E in Hemodialysis Patients
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