HereditaryNCT01201174
Hemolysis in Patients With Hereditary Spherocytosis (HS)
A study testing fermented papaya preparation (FPP) in people with Hereditary and Hemolysis, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
In the present study the investigators are going to explore the oxidative status of HS-RBC and its contribution to hemolysis Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hereditary, Hemolysis
- What is being tested?
- fermented papaya preparation (FPP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2010to Sep 2011
- 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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients > 5 years
- with documented family history of HS
- patients should have clinical and laboratory findings, consistent with mild to severe HS, diagnosed on the basis of spherocyte morphology, elevated MCHC (33-38 g/dl), with a mean value of (35.47 g/dl), increased osmotic fragility , splenomegaly and non-immune mediated hemolysis.
Who cannot join
- non
Trial locations and contacts
1 site in 1 country.
Israel1 site
Wolfsson Medical Center
Holon, Israel,
GHOTI HOSSAM, doctor, 970-35028110, drghoti123@yahoo.com
About this study
Official title: Oxidative Stress Contributes to Hemolysis in Patients With Hereditary Spherocytosis (HS) and Can be Ameliorated by Fermented Papaya Preparation (FPP)
In the present study the investigators are going to explore the oxidative status of HS-RBC and its contribution to hemolysis
Read the detailed description
The oxidative status of cells, which is determined by the balance between pro-oxidants, such as the reactive oxygen species (ROS), and antioxidants, is a major regulator of cellular functions. Impaired balance between pro- and antioxidants causes oxidative stress which may result in oxidation of proteins, lipids and DNA with the final outcome of premature cell aging and apoptosis [1,2]. Oxidatively stressed red blood cell (RBC) have been observed in various congenital and acquired hemolytic anemias, including thalassemia, sickle cell anemia, congenital dyserythropoietic anemia, G6PD deficiency and paroxysmal nocturnal hemoglobinuria (PNH) as well as in myelodysplastic syndrome (MDS). Although the primary etiology is different in these anemias, oxidative stress mediates several of their pathologies, mainly hemolysis [3].
Hereditary Spherocytosis (HS) is a genetic disorder of the RBC skeleton with primary deficiency in spectrin, ankyrin-1, band 3 or protein 4.2 associated with chronic hemolytic anemia [4]. Secondary protein deficiencies resulting from oxidative stress are often observed and may be involved in the clinical manifestations of the disease [5].
- Conditions
- Hereditary, Hemolysis
- Being tested
- fermented papaya preparation (FPP)
- Keywords
- Hemolysis in Patients with Hereditary Spherocytosis, with documented family history of HS., spherocyte morphology,, splenomegaly and non-immune mediated hemolysis.
- Medical subject headings
- Hemolysis, Splenomegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fermented papaya preparation (FPP)Other
Hemolysis will be assayed by suspending 3 ml of packed RBC in PBS or in the autologous plasma and overnight incubation in the presence of various concentrations of antioxidants such as fermented papaya preparation (FPP) at 37oC in humidified atmosphere of 5% CO2 in air (10). Following 5 min centrifugation at 800 rpm, the supernatants will collected for Hb determination by measuring the absorbance at 540 nm.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Hereditary Spherocytosis | No intervention | All patients should have clinical and laboratory findings, consistent with mild to severe HS, diagnosed on the basis of spherocyte morphology, elevated MCHC (33-38 g/dl), with a mean value of (35.47 g/dl), increased osmotic fragility , splenomegaly and non-immune mediated hemolysis. Receives: Other: fermented papaya preparation (FPP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROS, reduced glutathione (GSH) and lipid peroxides will be measured in RBC
ROS, reduced glutathione (GSH) and lipid peroxides will be measured in RBC following incubation with with 100 μM 2'-7'-dichlorofluorescin diacetate, 40 μM [1-(4-chloromercuryphenyl-azo-2-naphthol)] and fluor-DHPE, respectively for ROS [8] and with mercury orange for GSH [9]. After being washed twice, the cells will be resuspended in PBS and analyzed by flow cytometry .
Measured: year
Secondary outcomes (1)
Hemolysis
Hemolysis will be assayed by suspending 3 ml of packed RBC in PBS or in the autologous plasma and overnight incubation in the presence of various concentrations of antioxidants such as fermented papaya preparation (FPP)
Measured: year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HereditaryStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Investigators
- GHOTI HOSSAM, doctor, Principal investigator, HEMATOLOGY DEPARTMENT ON WOLFSSON MEDICAL CENTER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201174
- Sponsor's protocol ID
- SH-01CTIL
- Status last verified
- Sep 2010
- First submitted
- 12 Sep 2010
- Last updated
- 14 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxidative Stress Contributes to Hemolysis in Patients With Hereditary Spherocytosis (HS) and Can be Ameliorated by Fermented Papaya Preparation (FPP)
- ClinicalTrials.gov ID
- NCT01201174
- Acronym / sponsor ID
- SH-01CTIL
- Conditions
- Hereditary, Hemolysis
- Keywords
- Hemolysis in Patients with Hereditary Spherocytosis, with documented family history of HS., spherocyte morphology,, splenomegaly and non-immune mediated hemolysis.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 14 Sep 2010 (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.
In the present study the investigators are going to explore the oxidative status of HS-RBC and its contribution to hemolysis
Detailed description
The oxidative status of cells, which is determined by the balance between pro-oxidants, such as the reactive oxygen species (ROS), and antioxidants, is a major regulator of cellular functions. Impaired balance between pro- and antioxidants causes oxidative stress which may result in oxidation of proteins, lipids and DNA with the final outcome of premature cell aging and apoptosis [1,2]. Oxidatively stressed red blood cell (RBC) have been observed in various congenital and acquired hemolytic anemias, including thalassemia, sickle cell anemia, congenital dyserythropoietic anemia, G6PD deficiency and paroxysmal nocturnal hemoglobinuria (PNH) as well as in myelodysplastic syndrome (MDS). Although the primary etiology is different in these anemias, oxidative stress mediates several of their pathologies, mainly hemolysis [3].
Hereditary Spherocytosis (HS) is a genetic disorder of the RBC skeleton with primary deficiency in spectrin, ankyrin-1, band 3 or protein 4.2 associated with chronic hemolytic anemia [4]. Secondary protein deficiencies resulting from oxidative stress are often observed and may be involved in the clinical manifestations of the disease [5].
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Hereditary Spherocytosis | No intervention | Other: fermented papaya preparation (FPP)All patients should have clinical and laboratory findings, consistent with mild to severe HS, diagnosed on the basis of spherocyte morphology, elevated MCHC (33-38 g/dl), with a mean value of (35.47 g/dl), increased osmotic fragility , splenomegaly and non-immune mediated hemolysis. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients > 5 years
- with documented family history of HS
- patients should have clinical and laboratory findings, consistent with mild to severe HS, diagnosed on the basis of spherocyte morphology, elevated MCHC (33-38 g/dl), with a mean value of (35.47 g/dl), increased osmotic fragility , splenomegaly and non-immune mediated hemolysis.
Key exclusion criteria (1 listed)
- non
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 preparation (FPP)Hemolysis will be assayed by suspending 3 ml of packed RBC in PBS or in the autologous plasma and overnight incubation in the presence of various concentrations of antioxidants such as fermented papaya preparation (FPP) at 37oC in humidified atmosphere of 5% CO2 in air (10). Following 5 min centrifugation at 800 rpm, the supernatants will collected for Hb determination by measuring the absorbance at 540 nm. | Other | Patients with Hereditary Spherocytosis |
Primary outcome
ROS, reduced glutathione (GSH) and lipid peroxides will be measured in RBC
Time frame: year
ROS, reduced glutathione (GSH) and lipid peroxides will be measured in RBC following incubation with with 100 μM 2'-7'-dichlorofluorescin diacetate, 40 μM [1-(4-chloromercuryphenyl-azo-2-naphthol)] and fluor-DHPE, respectively for ROS [8] and with mercury orange for GSH [9]. After being washed twice, the cells will be resuspended in PBS and analyzed by flow cytometry .
1 secondary outcome
Hemolysis
Time frame: year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2010.
Related trials for Hereditary
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
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.
GHOTI HOSSAM, doctor principal investigator
HEMATOLOGY DEPARTMENT ON WOLFSSON MEDICAL CENTER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fermented papaya preparation (FPP) in people with Hereditary and Hemolysis, run by Wolfson Medical Center at 1 site in Israel.
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 3 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 14 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Ghoti Hossam, doctor (035028110, drghoti123@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ROS, reduced glutathione (GSH) and lipid peroxides will be measured in RBC (time frame: year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2010.