NCT02107053

Brief Summary

Atherosclerosis and its related cardiovascular morbidity and mortality, underlie many chronic diseases. Most atherosclerotic patients have multiple cardiovascular risk factors, which potentiate each other, causing a huge burden on health systems. In order to improve the understanding and treatment options of atherosclerosis, it is necessary to identify common basic pathways in its pathogenesis. Oxidative Stress (OS) has a major role in the pathogenesis of atherosclerosis; however, good biomarkers to determine OS are still missing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

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

First Submitted

Initial submission to the registry

February 18, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 9, 2016

Status Verified

February 1, 2016

Enrollment Period

1.5 years

First QC Date

February 18, 2014

Last Update Submit

February 7, 2016

Conditions

Cardiovascular Disease (CVD)

Keywords

Oxidative stress,hemodialysis,pomegranate juice,dietary supplementpatients

Outcome Measures

Primary Outcomes (1)

  • Oxidation reduction potential

    Each patient will serve as a self control. The metric measurements will be expressed as relative to control potential. Redox potential will be measured as oxidation-reduction potential and reported in millivolts.

    Immediately before and after dialysis, for 4 various protocols

Study Arms (3)

IV iron + PJ

EXPERIMENTAL

Each patient will serve as a self control

Dietary Supplement: PJDrug: IV iron

No IV iron + PJ

EXPERIMENTAL

Each patient will serve as a self control

Dietary Supplement: PJ

IV iron no PJ

EXPERIMENTAL

Each patient will serve as a self control

Drug: IV iron

Interventions

PJDIETARY_SUPPLEMENT
Also known as: pomegranate juice
IV iron + PJNo IV iron + PJ
IV ironDRUG

IV iron is routinely administered to dialysis patients worldwide to correct anemia

IV iron + PJIV iron no PJ

Eligibility Criteria

Age20 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients on hemodialysis

You may not qualify if:

  • patients with infections or cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Galilee Hospital

Nahariya, 22100, Israel

Location

Related Publications (12)

  • Shema-Didi L, Kristal B, Ore L, Shapiro G, Geron R, Sela S. Pomegranate juice intake attenuates the increase in oxidative stress induced by intravenous iron during hemodialysis. Nutr Res. 2013 Jun;33(6):442-6. doi: 10.1016/j.nutres.2013.04.004. Epub 2013 May 9.

    PMID: 23746559BACKGROUND

  • Shema-Didi L, Sela S, Ore L, Shapiro G, Geron R, Moshe G, Kristal B. One year of pomegranate juice intake decreases oxidative stress, inflammation, and incidence of infections in hemodialysis patients: a randomized placebo-controlled trial. Free Radic Biol Med. 2012 Jul 15;53(2):297-304. doi: 10.1016/j.freeradbiomed.2012.05.013. Epub 2012 May 17.

    PMID: 22609423BACKGROUND

  • Sela S, Michelis R, Kristal B. Are oxidative modifications of proteins a metabolomic signature of cardiovascular disease in CKD? Am J Kidney Dis. 2013 Feb;61(2):350-1. doi: 10.1053/j.ajkd.2012.10.022. No abstract available.

    PMID: 23318016BACKGROUND

  • Cohen-Mazor M, Sela S, Mazor R, Ilan N, Vlodavsky I, Rops AL, van der Vlag J, Cohen HI, Kristal B. Are primed polymorphonuclear leukocytes contributors to the high heparanase levels in hemodialysis patients? Am J Physiol Heart Circ Physiol. 2008 Feb;294(2):H651-8. doi: 10.1152/ajpheart.00952.2007. Epub 2007 Nov 21.

    PMID: 18032524BACKGROUND

  • Mazor R, Kristal B, Cohen-Mazor M, Yagil C, Yagil Y, Sela S. The polymorphonuclear leukocyte contributes to the development of hypertension in the Sabra rat. J Hypertens. 2007 Nov;25(11):2249-56. doi: 10.1097/HJH.0b013e3282dd79b6.

    PMID: 17921819BACKGROUND

  • Mazor R, Shurtz-Swirski R, Farah R, Kristal B, Shapiro G, Dorlechter F, Cohen-Mazor M, Meilin E, Tamara S, Sela S. Primed polymorphonuclear leukocytes constitute a possible link between inflammation and oxidative stress in hyperlipidemic patients. Atherosclerosis. 2008 Apr;197(2):937-43. doi: 10.1016/j.atherosclerosis.2007.08.014. Epub 2007 Sep 17.

    PMID: 17869258BACKGROUND

  • Jacobi J, Sela S, Cohen HI, Chezar J, Kristal B. Priming of polymorphonuclear leukocytes: a culprit in the initiation of endothelial cell injury. Am J Physiol Heart Circ Physiol. 2006 May;290(5):H2051-8. doi: 10.1152/ajpheart.01040.2005. Epub 2005 Dec 30.

    PMID: 16387791BACKGROUND

  • Jacobi J, Kristal B, Chezar J, Shaul SM, Sela S. Exogenous superoxide mediates pro-oxidative, proinflammatory, and procoagulatory changes in primary endothelial cell cultures. Free Radic Biol Med. 2005 Nov 1;39(9):1238-48. doi: 10.1016/j.freeradbiomed.2005.06.010. Epub 2005 Aug 8.

    PMID: 16214039BACKGROUND

  • Sela S, Shurtz-Swirski R, Cohen-Mazor M, Mazor R, Chezar J, Shapiro G, Hassan K, Shkolnik G, Geron R, Kristal B. Primed peripheral polymorphonuclear leukocyte: a culprit underlying chronic low-grade inflammation and systemic oxidative stress in chronic kidney disease. J Am Soc Nephrol. 2005 Aug;16(8):2431-8. doi: 10.1681/ASN.2004110929. Epub 2005 Jun 29.

    PMID: 15987755BACKGROUND

  • Sela S, Mazor R, Amsalam M, Yagil C, Yagil Y, Kristal B. Primed polymorphonuclear leukocytes, oxidative stress, and inflammation antecede hypertension in the Sabra rat. Hypertension. 2004 Nov;44(5):764-9. doi: 10.1161/01.HYP.0000144480.10207.34. Epub 2004 Sep 27.

    PMID: 15452031BACKGROUND

  • Shurtz-Swirski R, Sela S, Herskovits AT, Shasha SM, Shapiro G, Nasser L, Kristal B. Involvement of peripheral polymorphonuclear leukocytes in oxidative stress and inflammation in type 2 diabetic patients. Diabetes Care. 2001 Jan;24(1):104-10. doi: 10.2337/diacare.24.1.104.

    PMID: 11194213BACKGROUND

  • Kristal B, Shurtz-Swirski R, Chezar J, Manaster J, Levy R, Shapiro G, Weissman I, Shasha SM, Sela S. Participation of peripheral polymorphonuclear leukocytes in the oxidative stress and inflammation in patients with essential hypertension. Am J Hypertens. 1998 Aug;11(8 Pt 1):921-8. doi: 10.1016/s0895-7061(98)00099-5.

    PMID: 9715783BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

ferryl iron

Study Officials

  • Batya Kristal, MD

    Western Galilee Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research Labs

Study Record Dates

First Submitted

February 18, 2014

First Posted

April 8, 2014

Study Start

April 1, 2014

Primary Completion

October 1, 2015

Study Completion

January 1, 2016

Last Updated

February 9, 2016

Record last verified: 2016-02

Locations

IL(1)