AnemiaNCT03005847
The Effect of Fermented Papaya Preparation on Patients With Chronic Kidney Disease Under Dialysis Receiving Intravenous Iron
A study testing fermented papaya preparation in people with Anemia and Chronic Kidney Disease Stage 5, run by Hadassah Medical Organization.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anemia, Chronic Kidney Disease Stage 5
- What is being tested?
- fermented papaya preparation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2017to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Any evidence of acute bleeding. Hg level of less than 8 g/dL Patients with known allergy to Papaya
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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:
- 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.
- 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.
- Exclusion criteria:
Any evidence of acute bleeding. Hg level of less than 8 g/dL Patients with known allergy to Papaya
- Patients will be treated orally with FPP (3 gr. X 3 times a day) for 3 months.
- Blood samples will be obtained from all patients prior and during (every 2 weeks) treatment.
- 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.
- Conditions
- Anemia, Chronic Kidney Disease Stage 5
- Being tested
- fermented papaya preparation
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fermented papaya preparationDietary supplement
Also called FPP
dietary supplementation with fermented papaya preparation
| Study group | Role | What they receive |
|---|---|---|
| FPP arm | Experimental | active treatment with fermented papaya preparation Receives: Dietary Supplement: fermented papaya preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron status
evaluation of iron overload reduction after 3 months of treatment with fermented papaya preparation
Measured: 3 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startMar 2017
- Primary completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Itamr Sagiv, Hadassah Medical Organization
- Investigators
- itamar sagiv, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005847
- Sponsor's protocol ID
- FPP001-HMO-CTIL
- Status last verified
- Jan 2017
- First submitted
- 26 Dec 2016
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 20438538Ghoti 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.
PubMed 22435497Gaweda 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.
PubMed 24821751Amer 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.
PubMed 18384199Prus 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.
PubMed 22824747Bertuccelli 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.
PubMed 24750791Marotta 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.
PubMed 22824755Somanah 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.
PubMed 22330753Marotta 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.
PubMed 21382272Ghoti 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.
PubMed 21063708Aruoma 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.
PubMed 20870007Marotta 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.
PubMed 20370494Fibach 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.
PubMed 20127662Ghoti 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.
PubMed 19756600Marotta 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.
PubMed 17444858
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fermented Papaya Preparation on Patients With Chronic Kidney Disease Under Dialysis Receiving Intravenous Iron
- ClinicalTrials.gov ID
- NCT03005847
- Acronym / sponsor ID
- FPP001-HMO-CTIL
- Conditions
- Anemia, Chronic Kidney Disease Stage 5
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Mar 2017
- Primary completion
- Dec 2018 (estimated)
- First posted
- 29 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
- Exclusion criteria:
Any evidence of acute bleeding. Hg level of less than 8 g/dL Patients with known allergy to Papaya
- Patients will be treated orally with FPP (3 gr. X 3 times a day) for 3 months.
- Blood samples will be obtained from all patients prior and during (every 2 weeks) treatment.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FPP arm | Experimental | Dietary Supplement: fermented papaya preparationactive treatment with fermented papaya preparation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Any evidence of acute bleeding. Hg level of less than 8 g/dL Patients with known allergy to Papaya
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fermented papaya preparationAlso: FPPdietary supplementation with fermented papaya preparation | Dietary supplement | FPP arm |
Primary outcome
Iron status
Time frame: 3 months of treatment
evaluation of iron overload reduction after 3 months of treatment with fermented papaya preparation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
- Background: PubMed 20438538Amer 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.
- Background: PubMed 22435497Ghoti 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.
- Background: PubMed 24821751Gaweda 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.
- Background: PubMed 18384199Amer 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.
- Background: PubMed 22824747Prus 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.
- Background: PubMed 24750791Bertuccelli 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.
- Background: PubMed 22824755Marotta 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.
- Background: PubMed 22330753Somanah 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.
- Background: PubMed 21382272Marotta 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.
- Background: PubMed 21063708Ghoti 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.
- Background: PubMed 20870007Aruoma 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.
- Background: PubMed 20370494Marotta 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
itamar sagiv, MD principal investigator
Hadassah Medical Organization
Questions about this trial
What is this clinical trial studying?
A study testing fermented papaya preparation in people with Anemia and Chronic Kidney Disease Stage 5, run by Hadassah Medical Organization.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Itamar Sagiv, MD (97226776881, itamar@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iron status (time frame: 3 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03005847, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2017.