The Effect of Pomegranate Juice on Oxidative Stress in Hemodialysis Patients

March 22, 2010 updated by: Western Galilee Hospital-Nahariya

A Randomized Clinical Trial for Estimating the Effects of Pomegranate Juice Consumption by Hemodialysis Patients on Oxidative Stress, Infections, Cardiovascular Events and Mortality

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Nahariya, Israel, 22100
        • Western Galilee Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PG
Dietary supplement: Pomegranate juice
Experimental: PL
Dietary supplement: Placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western Galilee Hospital-Nahariya

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

July 27, 2008

First Submitted That Met QC Criteria

July 31, 2008

First Posted (Estimate)

August 4, 2008

Study Record Updates

Last Update Posted (Estimate)

March 23, 2010

Last Update Submitted That Met QC Criteria

March 22, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PJHD-23-7-08CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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