ThalassemiaNCT00972231
Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia
An observational study of Thalassemia and Sickle Cell Disease, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Iron overload impaired growth in Thalassemia patients due to iron deposition in the endocrine glands, including the hypophysis and gonads. The issue of iron overload in Sickle Cell Anemia is recently studied more extensively and preliminary studies shows that endocrine damage is rarer in those patients. Read more about this study
- Who is it for?
- Ages 5 to 45 years
- Conditions the study is for
- Thalassemia, Sickle Cell Disease
- What is being tested?
- Medical Chart Summary
- How many people
- 93 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2009to Dec 2010
- Phase
- Observational
- 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 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 150 patients suffering from hemoglobinopathies are treated at the Pediatric Hematology Unit, Ha'Emek Medical Center. This include Thalassemia Major blood transfused and treated by chelators, Thalassemia Intermedia patients ussualy not transfused, some of them treated by Hydroxyurea, and two groups of Sickle cell patients, Sickkle cell homozygous and Sickle cell thalassemia. Most of the Sickle cell patients are treated with Hydroxyurea.
Who may be able to join
- All patients in follow up with available medical charts.
Who cannot join
- Patients lost from follow up or without enough data to calculate growth velocity or clinical and laboratory endocrine assessment or missing data about iron status.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Pediatric Hematology Unit - Ha'Emek Medical Center
Afula, Afula, 18101
About this study
Iron overload impaired growth in Thalassemia patients due to iron deposition in the endocrine glands, including the hypophysis and gonads. The issue of iron overload in Sickle Cell Anemia is recently studied more extensively and preliminary studies shows that endocrine damage is rarer in those patients.
Growth velocity was not systematically studied in patients with Iron Overload, even in thalassemia patients in spite several studies that assess the endocrine function in those patients. In Sickle Cell Patients this issue was not studied.
The purpose of this study is to assess the growth velocity in a cohort of Thalassemia Major and Intermedia patients and compare the results to another group of Sickle Cell patients, including Sickle cell thalassemia.
Read the detailed description
Growth velocity, endocrine function and iron overload status will be studied in the patients that are in follow up at the Pediatric Hematology Unit, at the Ha'Emek Medical Center.
Patients who were lost from follow up or insufficient data about growth in the past will not included in the study.
- Conditions
- Thalassemia, Sickle Cell Disease
- Being tested
- Medical Chart Summary
- Keywords
- Thalassemia Major, Thalassemia Intermedia, Sickle Cell Anemia, Sickle Cell Thalassemia, Iron Overload, Growth Velocity
- Medical subject headings
- Thalassemia, Anemia, Sickle Cell, beta-Thalassemia, Iron Overload
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Chart SummaryOther
Summary of the Medical Files including annual growth velocity, endocrine function and iron overload status.
| Study group | Role | What they receive |
|---|---|---|
| Thalassemia Group | Patients suffering from Thalassemia Major and patients with Thalassemia Intermedia Receives: Other: Medical Chart Summary | |
| Sickle Cell Group | Patients with Sickle Cell Anemia and Sickle Cell Thalassemia Receives: Other: Medical Chart Summary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia
Analysis of Growth Velocity in Thalassemia and Sickle Cell Anemia and correlation with Iron Overload
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThalassemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Koren Ariel, HaEmek Medical Center, Israel
- Investigators
- Ariel Koren, MD, Principal investigator, Pediatric Dpt B and Pediatric Hemaology Unit - Ha'Emek Medical Center - Afula - IsraelCarina Levin, MD, Principal investigator, Pediatric Hematology Unit, Ha'Emek Medical Center, Afula, IsraelDaniela Mathov, Student, Principal investigator, Pediatic Hematology Unit, Ha'Emek Medical Center, Afula, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972231
- Sponsor's protocol ID
- 0133-08-EMC
- Status last verified
- Aug 2015
- First submitted
- 3 Sep 2009
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia
- ClinicalTrials.gov ID
- NCT00972231
- Acronym / sponsor ID
- 0133-08-EMC
- Conditions
- Thalassemia, Sickle Cell Disease
- Keywords
- Thalassemia Major, Thalassemia Intermedia, Sickle Cell Anemia, Sickle Cell Thalassemia, Iron Overload, Growth Velocity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 4 Sep 2009 (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.
Iron overload impaired growth in Thalassemia patients due to iron deposition in the endocrine glands, including the hypophysis and gonads. The issue of iron overload in Sickle Cell Anemia is recently studied more extensively and preliminary studies shows that endocrine damage is rarer in those patients.
Growth velocity was not systematically studied in patients with Iron Overload, even in thalassemia patients in spite several studies that assess the endocrine function in those patients. In Sickle Cell Patients this issue was not studied.
The purpose of this study is to assess the growth velocity in a cohort of Thalassemia Major and Intermedia patients and compare the results to another group of Sickle Cell patients, including Sickle cell thalassemia.
Detailed description
Growth velocity, endocrine function and iron overload status will be studied in the patients that are in follow up at the Pediatric Hematology Unit, at the Ha'Emek Medical Center.
Patients who were lost from follow up or insufficient data about growth in the past will not included in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thalassemia Group | – | Other: Medical Chart SummaryPatients suffering from Thalassemia Major and patients with Thalassemia Intermedia |
| Sickle Cell Group | – | Other: Medical Chart SummaryPatients with Sickle Cell Anemia and Sickle Cell Thalassemia |
Who may qualify
- Ages
- 5 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 150 patients suffering from hemoglobinopathies are treated at the Pediatric Hematology Unit, Ha'Emek Medical Center. This include Thalassemia Major blood transfused and treated by chelators, Thalassemia Intermedia patients ussualy not transfused, some of them treated by Hydroxyurea, and two groups of Sickle cell patients, Sickkle cell homozygous and Sickle cell thalassemia. Most of the Sickle cell patients are treated with Hydroxyurea.
Key inclusion criteria (1 listed)
- All patients in follow up with available medical charts.
Key exclusion criteria (1 listed)
- Patients lost from follow up or without enough data to calculate growth velocity or clinical and laboratory endocrine assessment or missing data about iron status.
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 |
|---|---|---|
| Medical Chart SummarySummary of the Medical Files including annual growth velocity, endocrine function and iron overload status. | Other | Sickle Cell Group, Thalassemia Group |
Primary outcome
Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia
Time frame: One year
Analysis of Growth Velocity in Thalassemia and Sickle Cell Anemia and correlation with Iron Overload
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
Related trials for Thalassemia
Active, not recruiting
Evaluation the Safety and Efficacy of KL003 Cell Injection in the Treatment of Transfusion-dependent β-thalassemia.
Transfusion-dependent Beta-Thalassemia
RecruitingObservational study
Growth and Development-related Outcomes in Children With Transfusion-dependent Beta-thalassemia After Gene Therapy
Transfusion-dependent Beta-Thalassemia, Gene Therapy
Not yet recruiting
Gene Therapy of Beta Thalassemia Using a Self-inactivating Lentiviral Vector
Beta-Thalassemia
RecruitingPhase 1/2
β-Thalassemia Treatment With KL003 Cell Injection
Transfusion-dependent Beta-Thalassemia
Active, not recruitingPhase 3
A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)
Non-Transfusion-dependent Alpha-Thalassemia, Non-Transfusion-dependent Beta-Thalassemia
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.
Ariel Koren, MD principal investigator
Pediatric Dpt B and Pediatric Hemaology Unit - Ha'Emek Medical Center - Afula - Israel
Carina Levin, MD principal investigator
Pediatric Hematology Unit, Ha'Emek Medical Center, Afula, Israel
Daniela Mathov, Student principal investigator
Pediatic Hematology Unit, Ha'Emek Medical Center, Afula, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thalassemia and Sickle Cell Disease, run by HaEmek Medical Center, Israel 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 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: finished, as of the sponsor's last update on 1 Sep 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia (time frame: One 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 1 Sep 2015.