Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia
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| ClinicalTrials.gov Identifier: NCT00972231 |
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Recruitment Status :
Completed
First Posted : September 4, 2009
Last Update Posted : September 1, 2015
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Sponsor:
HaEmek Medical Center, Israel
Information provided by (Responsible Party):
Dr Koren Ariel, HaEmek Medical Center, Israel
| Tracking Information | ||||||||||
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| First Submitted Date | September 3, 2009 | |||||||||
| First Posted Date | September 4, 2009 | |||||||||
| Last Update Posted Date | September 1, 2015 | |||||||||
| Study Start Date | January 2009 | |||||||||
| Actual Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
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
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| Original Primary Outcome Measures | Not Provided | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures | Not Provided | |||||||||
| Original Secondary Outcome Measures | Not Provided | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia | |||||||||
| Official Title | 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 | Observational | |||||||||
| Study Design | 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. | |||||||||
| Condition |
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| Intervention | Other: Medical Chart Summary
Summary of the Medical Files including annual growth velocity, endocrine function and iron overload status.
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| Study Groups/Cohorts |
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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 | Completed | |||||||||
| Actual Enrollment |
93 | |||||||||
| Original Estimated Enrollment |
150 | |||||||||
| Actual Study Completion Date | December 2010 | |||||||||
| Actual Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 5 Years to 45 Years (Child, Adult) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries | Israel | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT00972231 | |||||||||
| Other Study ID Numbers | 0133-08-EMC | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement | Not Provided | |||||||||
| Current Responsible Party | Dr Koren Ariel, HaEmek Medical Center, Israel | |||||||||
| Original Responsible Party | Ha'Emek Medical Center, Pediatric Hematology Unit | |||||||||
| Current Study Sponsor | HaEmek Medical Center, Israel | |||||||||
| Original Study Sponsor | Same as current | |||||||||
| Collaborators | Not Provided | |||||||||
| Investigators |
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| PRS Account | HaEmek Medical Center, Israel | |||||||||
| Verification Date | August 2015 | |||||||||