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The Effect of Pomegranate Juice on Oxidative Stress in Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00727519
Recruitment Status : Completed
First Posted : August 4, 2008
Last Update Posted : March 23, 2010
Information provided by:
Western Galilee Hospital-Nahariya

Brief Summary:
Pomegranate juice (PJ) consumption by hemodialysis patients will reduce the oxidative stress and the incidence of infections, cardiovascular events and mortality.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Hemodialysis Dietary Supplement: Pomegranate juice Dietary Supplement: Placebo Phase 3

Detailed Description:

The mortality rate in patients with end stage renal failure is substantially higher than in the general population, and deaths are mainly attributable to cardiovascular diseases and infections. There is accumulating evidence that supports the role for oxidative stress in damaging the immune system and in the pathogenesis of cardiovascular diseases in hemodialysis patients, therefore antioxidative treatment, which will reduce oxidative stress, may be beneficial.

Pomegranate juice contains antioxidants such as soluble polyphenols, tannins and anthocyanins and was shown to have anti-inflammatory, anti- bacterial and anti-atherosclerotic properties in mice and humans. However,the effects of pomegranate juice on oxidative stress, infections and cardiovascular events in hemodialysis patients are still not documented.

This is a randomized preventive intervention trial on hemodialysis patients from one dialysis centre in Israel. The patients will be enrolled and randomized to receive pomegranate juice or placebo. Patients will be followed for one year. The objective of this study is to investigate the effects of pomegranate juice (PJ) consumption by hemodialysis patients on the changes in oxidative stress and the incidence of infections, cardiovascular events and mortality.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Prevention
Official Title: A Randomized Clinical Trial for Estimating the Effects of Pomegranate Juice Consumption by Hemodialysis Patients on Oxidative Stress, Infections, Cardiovascular Events and Mortality
Study Start Date : July 2008
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: PG Dietary Supplement: Pomegranate juice
Experimental: PL Dietary Supplement: Placebo

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • End Stage Renal Disease, stable chronic hemodialysis > 3 months
  • Informed Consent.
  • Man and women over 18 years.

Exclusion Criteria:

  • Hemodialysis < 3 months
  • Participation in other clinical trial
  • Not eligible according to physician decision

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00727519

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Western Galilee hospital
Nahariya, Israel, 22100
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. Batya Kristal, Western Galilee Hospital-Nahariya Identifier: NCT00727519    
Other Study ID Numbers: PJHD-23-7-08CTIL
First Posted: August 4, 2008    Key Record Dates
Last Update Posted: March 23, 2010
Last Verified: March 2010
Keywords provided by Western Galilee Hospital-Nahariya:
Pomegranate Juice
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency