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
About this trial
This is an interventional prevention trial for End Stage Renal Disease focused on measuring Hemodialysis, Nephrology, Pomegranate Juice, Israel
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
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
NCT ID
NCT00727519
First Posted
July 27, 2008
Last Updated
March 22, 2010
Sponsor
Western Galilee Hospital-Nahariya
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
Learn more about this trial
The Effect of Pomegranate Juice on Oxidative Stress in Hemodialysis Patients
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