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Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Koren Ariel, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00972231
First received: September 3, 2009
Last updated: August 30, 2015
Last verified: August 2015

September 3, 2009
August 30, 2015
January 2009
December 2010   (final data collection date for primary outcome measure)
Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia [ Time Frame: One year ] [ Designated as safety issue: No ]
Analysis of Growth Velocity in Thalassemia and Sickle Cell Anemia and correlation with Iron Overload
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Complete list of historical versions of study NCT00972231 on ClinicalTrials.gov Archive Site
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Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia
Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample
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.
  • Thalassemia
  • Sickle Cell Disease
Other: Medical Chart Summary
Summary of the Medical Files including annual growth velocity, endocrine function and iron overload status.
  • Thalassemia Group
    Patients suffering from Thalassemia Major and patients with Thalassemia Intermedia
    Intervention: Other: Medical Chart Summary
  • Sickle Cell Group
    Patients with Sickle Cell Anemia and Sickle Cell Thalassemia
    Intervention: Other: Medical Chart Summary
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
93
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients in follow up with available medical charts.

Exclusion Criteria:

  • 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.
Both
5 Years to 45 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00972231
0133-08-EMC
No
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Dr Koren Ariel, HaEmek Medical Center, Israel
HaEmek Medical Center, Israel
Not Provided
Principal Investigator: Ariel Koren, MD Pediatric Dpt B and Pediatric Hemaology Unit - Ha'Emek Medical Center - Afula - Israel
Principal Investigator: Carina Levin, MD Pediatric Hematology Unit, Ha'Emek Medical Center, Afula, Israel
Principal Investigator: Daniela Mathov, Student Pediatic Hematology Unit, Ha'Emek Medical Center, Afula, Israel
HaEmek Medical Center, Israel
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP