The Effect of Pomegranate Juice on Oxidative Stress in Hemodialysis Patients

This study has been completed.
Sponsor:
Information provided by:
Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier:
NCT00727519
First received: July 27, 2008
Last updated: March 22, 2010
Last verified: March 2010
  Purpose

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


Condition Intervention Phase
End Stage Renal Disease
Hemodialysis
Dietary Supplement: Pomegranate juice
Dietary Supplement: Placebo
Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Western Galilee Hospital-Nahariya:

Study Start Date: July 2008
Study Completion Date: January 2010
Arms Assigned Interventions
Experimental: PG Dietary Supplement: Pomegranate juice
Experimental: PL Dietary Supplement: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00727519

Locations
Israel
Western Galilee hospital
Nahariya, Israel, 22100
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
  More Information

No publications provided by Western Galilee Hospital-Nahariya

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Batya Kristal, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier: NCT00727519     History of Changes
Other Study ID Numbers: PJHD-23-7-08CTIL
Study First Received: July 27, 2008
Last Updated: March 22, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Western Galilee Hospital-Nahariya:
Hemodialysis
Nephrology
Pomegranate Juice
Israel

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Cardiovascular Infections
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Infection
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014