The Effect of Pomegranate Juice on Oxidative Stress in Hemodialysis Patients
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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 |
| 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 |
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
More Information
No publications provided
| 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 May 23, 2013