Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia
Recruitment status was Recruiting
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| First Received Date ICMJE | September 3, 2009 | ||||||||||||
| Last Updated Date | September 10, 2009 | ||||||||||||
| Start Date ICMJE | January 2009 | ||||||||||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Change History | Complete list of historical versions of study NCT00972231 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia | ||||||||||||
| Official Title ICMJE | Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia | ||||||||||||
| Brief 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. 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||||||||||
| Biospecimen | Not Provided | ||||||||||||
| Sampling Method | Non-Probability Sample | ||||||||||||
| 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. |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Medical Chart Summary
Summary of the Medical Files including annual growth velocity, endocrine function and iron overload status. |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 150 | ||||||||||||
| Estimated Completion Date | July 2010 | ||||||||||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 5 Years to 45 Years | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00972231 | ||||||||||||
| Other Study ID Numbers ICMJE | 0133-08-EMC | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| Responsible Party | Ha'Emek Medical Center, Pediatric Hematology Unit | ||||||||||||
| Study Sponsor ICMJE | HaEmek Medical Center, Israel | ||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | HaEmek Medical Center, Israel | ||||||||||||
| Verification Date | September 2009 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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