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The Effect of Pomegranate Juice on Oxidative Stress in Hemodialysis Patients

Primary Purpose

End Stage Renal Disease, Hemodialysis

Status
Completed
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Pomegranate juice
Placebo
Sponsored by
Western Galilee Hospital-Nahariya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for End Stage Renal Disease focused on measuring Hemodialysis, Nephrology, Pomegranate Juice, Israel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Western Galilee hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PG

PL

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 27, 2008
Last Updated
March 22, 2010
Sponsor
Western Galilee Hospital-Nahariya
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1. Study Identification

Unique Protocol Identification Number
NCT00727519
Brief Title
The Effect of Pomegranate Juice on Oxidative Stress in Hemodialysis Patients
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 Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Western Galilee Hospital-Nahariya

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Hemodialysis
Keywords
Hemodialysis, Nephrology, Pomegranate Juice, Israel

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3

8. Arms, Groups, and Interventions

Arm Title
PG
Arm Type
Experimental
Arm Title
PL
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Pomegranate juice
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Western Galilee hospital
City
Nahariya
ZIP/Postal Code
22100
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
24593225
Citation
Shema-Didi L, Kristal B, Sela S, Geron R, Ore L. Does Pomegranate intake attenuate cardiovascular risk factors in hemodialysis patients? Nutr J. 2014 Mar 4;13:18. doi: 10.1186/1475-2891-13-18.
Results Reference
derived

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The Effect of Pomegranate Juice on Oxidative Stress in Hemodialysis Patients

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