NCT01562340

Brief Summary

In this study, the investigators will administer pomegranate juice or fruit extract as a targeted antioxidant therapy to hemodialysis patients. The investigators will examine whether these pomegranate products will be safe and well-tolerated. The investigators will also examine whether these products may lead to improvements in blood serum biomarkers of:

  • oxidative stress status
  • inflammatory status
  • endothelial dysfunction

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

9 months

First QC Date

March 21, 2012

Last Update Submit

May 26, 2015

Conditions

End Stage Renal DiseaseCardiovascular DiseaseInflammation

Keywords

HemodialysisEnd stage renal diseaseOxidative stressInflammationEndothelial dysfunctionCardiovascular diseaseAntioxidantsFlavonoids

Outcome Measures

Primary Outcomes (3)

  • Markers of oxidative stress

    Oxidative stress: F2-isoprostanes

    12 weeks

  • Markers of inflammation

    Inflammation: C-reactive protein, Interleukin-6, and white blood cell count

    12 weeks

  • Markers of endothelial function

    Endothelial function: Monocyte functional assays (cytokines)

    12 weeks

Secondary Outcomes (1)

  • Number of subjects with adverse events and type of event

    12 weeks

Study Arms (2)

Pomegranate fruit extract

ACTIVE COMPARATOR
Other: Pomegranate fruit extract

Pomegranate juice

ACTIVE COMPARATOR
Other: Pomegranate juice

Interventions

Pomegranate juiceOTHER

Pomegranate juice (100 mL) 3 times per week (taken prior to hemodialysis session) for 4 weeks. Followed by 4 week wash-out (no intervention), then crossover to Comparator arm.

Also known as: Research Juice 100%
Pomegranate juice
Pomegranate fruit extractOTHER

Pomegranate fruit extract in single capsule (1050 mg) daily by mouth for 4 weeks. Followed by 4 week wash-out (no intervention), then crossover to Comparator arm.

Also known as: Clinical Active POMxp
Pomegranate fruit extract

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with end-stage renal disease receiving thrice weekly hemodialysis
  • Age \> 18 or \< 85 years
  • Life expectancy greater than one year
  • Ability to understand and provide informed consent for participation in the study

You may not qualify if:

  • History of poor adherence to hemodialysis or medical regimen
  • Prisoners, patients with significant mental illness, and other vulnerable populations
  • Active malignancy excluding basal cell carcinoma of the skin
  • Gastrointestinal dysfunction requiring parenteral nutrition
  • History of functional kidney transplant \< 6 months prior to study entry
  • Anticipated live donor kidney transplant
  • Patients taking vitamin E supplements \> 60 IU/day, vitamin C \> 150 mg/day or other antioxidant or nutritional supplements
  • Incident hemodialysis patients (defined as within 30 days of dialysis initiation)
  • Patients hospitalized for more than 5 days within the past 30 days.
  • Patients with a history of a major atherosclerotic event (defined as combined incidence of myocardial infarction, urgent target-vessel revascularization, coronary bypass surgery, and stroke) within three months
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwest Kidney Centers

Seattle, Washington, 98122, United States

Location

Related Publications (1)

  • Rivara MB, Mehrotra R, Linke L, Ruzinski J, Ikizler TA, Himmelfarb J. A pilot randomized crossover trial assessing the safety and short-term effects of pomegranate supplementation in hemodialysis patients. J Ren Nutr. 2015 Jan;25(1):40-9. doi: 10.1053/j.jrn.2014.07.006. Epub 2014 Sep 11.

    PMID: 25218876DERIVED

Related Links

MeSH Terms

Conditions

Kidney Failure, ChronicCardiovascular DiseasesInflammation

Interventions

pomegranate fruit rind

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jonathan Himmelfarb, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

March 21, 2012

First Posted

March 23, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

US(1)