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

January 18, 2017 updated by: Itamr Sagiv, Hadassah Medical Organization
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background and rationale

Patients with chronic kidney disease (CKD) on hemodialysis often suffer from anemia. The anemia is primarily caused by insufficient production by the failing kidneys of the erythroid stimulating hormone - erythropoietin (Epo). Oxidative stress may be another reason for anemia. Oxidative stress in RBCs of these patients may be caused by:

  1. Passage of the blood through the plastic tubing during the dialysis procedure. We have shown oxidative stress in RBCs following passage of blood through similar tubing during leukopheresis procedure (1). Other groups reported similar effects during hemodialysis.

  2. Iron overload - In order to maximize the effect of Epo, the treatment is supplemented by IV injection of iron. This iron may accumulate and cause iron overload in some hemodialyzed patients. Under normal conditions, iron is transported in the blood and enters into cells following binding the plasma protein transferrin. However, when iron content in the plasma exceeds the binding capacity of transferrin, non-transferrin-bound iron (NTBI) appears. This iron enters cells via alternative pathways, and accumulates in the cytosol, where it participates in chemical reactions (Haber-Weiss, Fenton) that generate reactive oxygen species (ROS). Excess ROS overcomes the protective cellular anti-oxidant mechanisms and becomes cytotoxic. In the erythroid system, excess ROS causes accelerated apoptosis (programmed cell death) of precursor cells in the bone marrow and a short survival of mature RBCs in the circulation, resulting in chronic anemia. Excess iron and ROS may also damage other cells and lead to malfunctioning of vital organs, such as the heart and liver (2,3).

    FPP has been reported to bind and neutralize (scavenge) ROS (4) as well as free iron (chelate) (5). Both activities ameliorate the oxidative stress.

    Treatment with FPP of various diseases associated with oxidative stress, administered orally (3 gr. X 3 times a day), have been shown to significantly ameliorate the symptoms underlying these diseases (6-18). FPP has a long track-record of safe human consumption (19-20). It has been used for many years as a food-supplement by thousands of people around the world without any reported side effect.

    Research goals

    To study the effect of fermented papaya preparation (FPP) on patients with chronic kidney disease (CKD) under dialysis, receiving intravenous iron.

    General Protocol:

    This will be a single-arm, open-label, single-center study in 20 patients upon dialysis receiving IV iron supplementation. All participants will be treated with FPP for 3 months.

    Bi-weekly, blood samples will be drawn and the patients will be monitored for assessment of safety and efficacy.

    Detailed Protocol Twenty patients, treated on Hadassah Medical center, Jerusalem, will be screened and recruited according to clinical criteria.

    inclusion criteria: 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.

  3. Exclusion criteria:

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

3. Patients will be treated orally with FPP (3 gr. X 3 times a day) for 3 months.

4. Blood samples will be obtained from all patients prior and during (every 2 weeks) treatment.

5. Samples will be analyzed for:

Blood chemistry for Potassium, Albumin and Phosphorous (every 2 weeks).

Anemia: Complete blood count, including RBC number and indexes, as well as hemoglobin content.

Oxidative stress: (once monthly) Reactive oxygen species Reduced glutathione Membrane lipid peroxidation External phosphatidylserine

Iron overload: (once monthly) Serum ferritin Serum transferin. Labile plasma iron Serum hepcidin Intracellular labile iron pool

Safety measures:

Adverse events: Frequency, severity, seriousness, time to onset, duration, and relatedness to study product.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

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Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FPP arm
active treatment with fermented papaya preparation
Dietary supplement: fermented papaya preparation
dietary supplementation with fermented papaya preparation
Other Names:
  • FPP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Iron status
Time Frame: 3 months of treatment
evaluation of iron overload reduction after 3 months of treatment with fermented papaya preparation
3 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hadassah Medical Organization

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: itamar sagiv, MD, Hadassah Medical Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 26, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 19, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FPP001-HMO-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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