The Effect of Fermented Papaya Preparation on Patients With Chronic Kidney Disease Under Dialysis Receiving Intravenous Iron

NCT03005847 | Unknown

• 1 other identifier: FPP001-HMO-CTIL
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Fermented papaya preparation has been reported to bind and neutralize reactive oxygen species as well as iron. Patients undergoing hemodialysis are generally on iron overload status due to their inability to use iron storage adequately. The aim of this study is to evaluate the effect of FPP on the iron status of these patients.

Conditions

Anemia; Chronic Kidney Disease Stage 5

Outcome Measures

Primary Outcomes (1)

• Iron status

  evaluation of iron overload reduction after 3 months of treatment with fermented papaya preparation

  3 months of treatment

Study Arms (1)

FPP arm

EXPERIMENTAL

active treatment with fermented papaya preparation

Dietary Supplement: fermented papaya preparation

Interventions

fermented papaya preparation DIETARY_SUPPLEMENT

dietary supplementation with fermented papaya preparation

Also known as: FPP

FPP arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70. Any primary kidney disease resulting in ESRD. Hemodynamically stable status. PTH up to 2-9 times upper normal limits. Patients receiving ESA may be included.

You may not qualify if:

• Any evidence of acute bleeding. Hg level of less than 8 g/dL Patients with known allergy to Papaya

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Related Publications (19)

• Amer J, Frankenburg S, Fibach E. Apheresis induces oxidative stress in blood cells. Ther Apher Dial. 2010 Apr;14(2):166-71. doi: 10.1111/j.1744-9987.2009.00746.x.

  PMID: 20438538 BACKGROUND

• Ghoti H, Rachmilewitz EA, Simon-Lopez R, Gaber R, Katzir Z, Konen E, Kushnir T, Girelli D, Campostrini N, Fibach E, Goitein O. Evidence for tissue iron overload in long-term hemodialysis patients and the impact of withdrawing parenteral iron. Eur J Haematol. 2012 Jul;89(1):87-93. doi: 10.1111/j.1600-0609.2012.01783.x. Epub 2012 May 18.

  PMID: 22435497 BACKGROUND

• Gaweda AE, Ginzburg YZ, Chait Y, Germain MJ, Aronoff GR, Rachmilewitz E. Iron dosing in kidney disease: inconsistency of evidence and clinical practice. Nephrol Dial Transplant. 2015 Feb;30(2):187-96. doi: 10.1093/ndt/gfu104. Epub 2014 May 12.

  PMID: 24821751 BACKGROUND

• Amer J, Goldfarb A, Rachmilewitz EA, Fibach E. Fermented papaya preparation as redox regulator in blood cells of beta-thalassemic mice and patients. Phytother Res. 2008 Jun;22(6):820-8. doi: 10.1002/ptr.2379.

  PMID: 18384199 BACKGROUND

• Prus E, Fibach E. The antioxidant effect of fermented papaya preparation involves iron chelation. J Biol Regul Homeost Agents. 2012 Apr-Jun;26(2):203-10.

  PMID: 22824747 BACKGROUND

• Bertuccelli G, Marotta F, Zerbinati N, Cabeca A, He F, Jain S, Lorenzetti A, Yadav H, Milazzo M, Calabrese F, Tomella C, Catanzaro R. Iron supplementation in young iron-deficient females causes gastrointestinal redox imbalance: protective effect of a fermented nutraceutical. J Biol Regul Homeost Agents. 2014 Jan-Mar;28(1):53-63.

  PMID: 24750791 BACKGROUND

• Marotta F, Naito Y, Jain S, Lorenzetti A, Soresi V, Kumari A, Carrera Bastos P, Tomella C, Yadav H. Is there a potential application of a fermented nutraceutical in acute respiratory illnesses? An in-vivo placebo-controlled, cross-over clinical study in different age groups of healthy subjects. J Biol Regul Homeost Agents. 2012 Apr-Jun;26(2):285-94.

  PMID: 22824755 BACKGROUND

• Somanah J, Aruoma OI, Gunness TK, Kowelssur S, Dambala V, Murad F, Googoolye K, Daus D, Indelicato J, Bourdon E, Bahorun T. Effects of a short term supplementation of a fermented papaya preparation on biomarkers of diabetes mellitus in a randomized Mauritian population. Prev Med. 2012 May;54 Suppl:S90-7. doi: 10.1016/j.ypmed.2012.01.014. Epub 2012 Feb 11.

  PMID: 22330753 BACKGROUND

• Marotta F, Chui DH, Jain S, Polimeni A, Koike K, Zhou L, Lorenzetti A, Shimizu H, Yang H. Effect of a fermented nutraceutical on thioredoxin level and TNF-alpha signalling in cirrhotic patients. J Biol Regul Homeost Agents. 2011 Jan-Mar;25(1):37-45.

  PMID: 21382272 BACKGROUND

• Ghoti H, Fibach E, Dana M, Abu Shaban M, Jeadi H, Braester A, Matas Z, Rachmilewitz E. Oxidative stress contributes to hemolysis in patients with hereditary spherocytosis and can be ameliorated by fermented papaya preparation. Ann Hematol. 2011 May;90(5):509-13. doi: 10.1007/s00277-010-1110-2. Epub 2010 Nov 10.

  PMID: 21063708 BACKGROUND

• Aruoma OI, Hayashi Y, Marotta F, Mantello P, Rachmilewitz E, Montagnier L. Applications and bioefficacy of the functional food supplement fermented papaya preparation. Toxicology. 2010 Nov 28;278(1):6-16. doi: 10.1016/j.tox.2010.09.006. Epub 2010 Sep 24.

  PMID: 20870007 BACKGROUND

• Marotta F, Koike K, Lorenzetti A, Jain S, Signorelli P, Metugriachuk Y, Mantello P, Locorotondo N. Regulating redox balance gene expression in healthy individuals by nutraceuticals: a pilot study. Rejuvenation Res. 2010 Apr-Jun;13(2-3):175-8. doi: 10.1089/rej.2009.0950.

  PMID: 20370494 BACKGROUND

• Fibach E, Tan ES, Jamuar S, Ng I, Amer J, Rachmilewitz EA. Amelioration of oxidative stress in red blood cells from patients with beta-thalassemia major and intermedia and E-beta-thalassemia following administration of a fermented papaya preparation. Phytother Res. 2010 Sep;24(9):1334-8. doi: 10.1002/ptr.3116.

  PMID: 20127662 BACKGROUND

• Ghoti H, Rosenbaum H, Fibach E, Rachmilewitz EA. Decreased hemolysis following administration of antioxidant-fermented papaya preparation (FPP) to a patient with PNH. Ann Hematol. 2010 Apr;89(4):429-30. doi: 10.1007/s00277-009-0821-8. Epub 2009 Sep 15. No abstract available.

  PMID: 19756600 BACKGROUND

• Marotta F, Yoshida C, Barreto R, Naito Y, Packer L. Oxidative-inflammatory damage in cirrhosis: effect of vitamin E and a fermented papaya preparation. J Gastroenterol Hepatol. 2007 May;22(5):697-703. doi: 10.1111/j.1440-1746.2007.04937.x.

  PMID: 17444858 BACKGROUND

• Danese C, Esposito D, D'Alfonso V, Cirene M, Ambrosino M, Colotto M. Plasma glucose level decreases as collateral effect of fermented papaya preparation use. Clin Ter. 2006 May-Jun;157(3):195-8.

  PMID: 16900843 BACKGROUND

• Marotta F, Weksler M, Naito Y, Yoshida C, Yoshioka M, Marandola P. Nutraceutical supplementation: effect of a fermented papaya preparation on redox status and DNA damage in healthy elderly individuals and relationship with GSTM1 genotype: a randomized, placebo-controlled, cross-over study. Ann N Y Acad Sci. 2006 May;1067:400-7. doi: 10.1196/annals.1354.057.

  PMID: 16804018 BACKGROUND

• Marotta F, Barreto R, Tajiri H, Bertuccelli J, Safran P, Yoshida C, Fesce E. The aging/precancerous gastric mucosa: a pilot nutraceutical trial. Ann N Y Acad Sci. 2004 Jun;1019:195-9. doi: 10.1196/annals.1297.031.

  PMID: 15247013 BACKGROUND

• Marotta F, Koike K, Lorenzetti A, Naito Y, Fayet F, Shimizu H, Marandola P. Nutraceutical strategy in aging: targeting heat shock protein and inflammatory profile through understanding interleukin-6 polymorphism. Ann N Y Acad Sci. 2007 Nov;1119:196-202. doi: 10.1196/annals.1404.011.

  PMID: 18056967 BACKGROUND

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic

Interventions

fermented papaya preparation

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• itamar sagiv, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Itamar Sagiv, MD

CONTACT

97226776881; itamar@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: primary investigator

Study Record Dates

• First Submitted: December 26, 2016
• First Posted: December 29, 2016
• Study Start: March 1, 2017
• Primary Completion: December 1, 2018
• Last Updated: January 19, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share