HemodialysisPhase 2NCT01001845
Comparative Effects of Milk Thistle Extract With Vitamin-E in Hemodialysis Patients
A Phase 2 study testing Milk Thistle extract, vit E and vit E + Milk Thistle extract in people with Hemodialysis and End Stage Renal Disease, run by Shiraz University of Medical Sciences at 1 site in Iran.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hemodialysis, End Stage Renal Disease
- What is being tested?
- Milk Thistle extract, vit E and vit E + Milk Thistle extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIran
- Study dates
- Jun 2009to May 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Milk Thistle Extract With Vitamin-E on Oxidative Stress Biomarkers in Hemodialysis Patients
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
- Being tested
- Milk Thistle extract, vit E, vit E + Milk Thistle extract
- Keywords
- hemodialysis, oxidative stress, plasma malondialdehyde, Glutathion peroxidase
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk Thistle extractDrug
1 tablet equivalent to 140 mg of silymarin, 3 times daily for 3 weeks
vit EDrug
200 mg twice daily for 3 weeks
vit E + Milk Thistle extractDrug
200 mg vit E twice daily + 1 tablet of Milk Thistle 3 times daily for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | No intervention | Not described |
| vit E | Active comparator | 200mg 2 times per day for 3 weeks Receives: Drug: vit E |
| Milk Thistle extract | Experimental | 1 tablet (equivalent to 140 mg silymarin) 3 times a day for 3 weeks Receives: 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 Receives: Drug: vit E + Milk Thistle extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
RBC Glutathion Peroxidase level
Measured: 3 weeks
Secondary outcomes (1)
Plasma malondialdehyde
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startJun 2009
- Primary completionMar 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Ghazal Vessal, PharmD, PhD, Study director, Shiraz University of Medical Sciences, Faculty of PharmacyBahram Shahriari, MD, Principal investigator, Shiraz University of Medical SciencesJamshid Roozbeh, MD, Study chair, Nephrology Urology Research Center, Shiraz University of Medical Sciencesmasoumeh Akmali, PhD, Principal investigator, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001845
- Sponsor's protocol ID
- 53001
- Status last verified
- Sep 2010
- First submitted
- 26 Oct 2009
- Last updated
- 24 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Milk Thistle Extract With Vitamin-E on Oxidative Stress Biomarkers in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01001845
- Acronym / sponsor ID
- 53001
- Conditions
- Hemodialysis, End Stage Renal Disease
- Keywords
- hemodialysis, oxidative stress, plasma malondialdehyde, Glutathion peroxidase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 27 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | No intervention | – |
| vit E | Active comparator | Drug: vit E200mg 2 times per day for 3 weeks |
| Milk Thistle extract | Experimental | Drug: Milk Thistle extract1 tablet (equivalent to 140 mg silymarin) 3 times a day for 3 weeks |
| vit E + Milk Thistle Extract | Experimental | Drug: vit E + Milk Thistle extract200mg vit E twice a day + 1 tablet of Milk Thistle extract 3 times a day for 3 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Milk Thistle extract1 tablet equivalent to 140 mg of silymarin, 3 times daily for 3 weeks | Drug | Milk Thistle extract |
| vit E200 mg twice daily for 3 weeks | Drug | vit E |
| vit E + Milk Thistle extract200 mg vit E twice daily + 1 tablet of Milk Thistle 3 times daily for 3 weeks | Drug | vit E + Milk Thistle Extract |
Primary outcome
RBC Glutathion Peroxidase level
Time frame: 3 weeks
1 secondary outcome
Plasma malondialdehyde
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ghazal Vessal, PharmD, PhD study director
Shiraz University of Medical Sciences, Faculty of Pharmacy
Bahram Shahriari, MD principal investigator
Shiraz University of Medical Sciences
Jamshid Roozbeh, MD study chair
Nephrology Urology Research Center, Shiraz University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Milk Thistle extract, vit E and vit E + Milk Thistle extract in people with Hemodialysis and End Stage Renal Disease, run by Shiraz University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RBC Glutathion Peroxidase level (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2011.