Clinical and Laboratory Assessment of Iron Overload in Sickle Cell Anemia and Sickle Cell Thalassemia
This study has been completed.
Sponsor:
HaEmek Medical Center, Israel
Information provided by (Responsible Party):
Dr Koren Ariel, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00512564
First received: August 5, 2007
Last updated: August 25, 2011
Last verified: August 2011
| Tracking Information | |||||
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| First Received Date ICMJE | August 5, 2007 | ||||
| Last Updated Date | August 25, 2011 | ||||
| Start Date ICMJE | September 2008 | ||||
| Primary Completion Date | December 2010 (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 NCT00512564 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 | Clinical and Laboratory Assessment of Iron Overload in Sickle Cell Anemia and Sickle Cell Thalassemia | ||||
| Official Title ICMJE | Clinical and Laboratory Assessment of Iron Overload in Sickle Cell Anemia and Sickle Cell Thalassemia - An Observational and Laboratory Study | ||||
| Brief Summary | Iron overload is well study in Thalassemia patients and it's not only related to blood transfusions, since intestinal iron absorption is also increased in those patients. Sickle cell patients didn't developed significant clinical symptoms and signs of iron overload in spite frequent transfusions. The purpose of this study is to assess the iron overload in Sickle cell anemia and Sickle cell Thalassemia patients using clinical parameters and laboratory studies including Non Transferrin Binding Iron, Labile Iron and Hepcidin, in order to determine the cardiac and liver iron. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | All tha patinets suffering from Sickle cell disease trreated at the Pediatric Hematology Unit |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Laboratory analyses of iron overload
Summary of clinical status related to iron overload and laboratory analysis of Iron overload including Total serum Iron, Transferrin, Ferritin and Non transferrin Binding Iron and Labile Plasma Iron |
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| Study Group/Cohort (s) | 1
Patients suffering from Sickle cell disease
Intervention: Other: Laboratory analyses of iron overload |
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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 | Completed | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Completion Date | December 2010 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00512564 | ||||
| Other Study ID Numbers ICMJE | 0087-07-EMC | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Dr Koren Ariel, HaEmek Medical Center, Israel | ||||
| 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 | August 2011 | ||||
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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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