The Effect of Pomegranate Juice on Oxidative Stress in Hemodialysis Patients

Phase 3

Completed

• Conditions: End Stage Renal Disease; Hemodialysis
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Pomegranate juice

• Registration Number: NCT00727519
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-27
• Study First Submitted QC: 2008-07-31
• Study First Posted: 2008-08-04
• Study Completion: 2010-01
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-22
• Last Update Posted: 2010-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PL	Placebo	-
PG	Pomegranate juice	-

Trial Locations

Locations (1)

Western Galilee hospital; 🇮🇱 Nahariya, Israel