The Effect of Pomegranate Juice on Oxidative Stress in Hemodialysis Patients

NCT ID: NCT00727519

Last Updated: 2010-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-01-31

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.

Conditions

End Stage Renal Disease; Hemodialysis

Study Design

• Primary Study Purpose: PREVENTION

Study Groups

PG

Group Type: EXPERIMENTAL

Pomegranate juice

Intervention Type: DIETARY_SUPPLEMENT

PL

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Pomegranate juice

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Western Galilee Hospital-Nahariya

OTHER_GOV

Sponsor Role: lead

Responsible Party

Western Galilee Hospital-Nahariya

Locations

Western Galilee hospital

Nahariya, Israel, Israel

Countries

Israel

References

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.

Reference Type: DERIVED

PMID: 24593225 (View on PubMed)

Other Identifiers

PJHD-23-7-08CTIL

Identifier Type: -

Identifier Source: org_study_id