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Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00972231
Recruitment Status : Completed
First Posted : September 4, 2009
Last Update Posted : September 1, 2015
Sponsor:
Information provided by (Responsible Party):
Dr Koren Ariel, HaEmek Medical Center, Israel

Study Description
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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.


Condition or disease Intervention/treatment
Thalassemia Sickle Cell Disease Other: Medical Chart Summary

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
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Study Type : Observational
Actual Enrollment : 93 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia
Study Start Date : January 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Thalassemia Group
Patients suffering from Thalassemia Major and patients with Thalassemia Intermedia
 Other: Medical Chart Summary
Summary of the Medical Files including annual growth velocity, endocrine function and iron overload status.
Sickle Cell Group
Patients with Sickle Cell Anemia and Sickle Cell Thalassemia
 Other: Medical Chart Summary
Summary of the Medical Files including annual growth velocity, endocrine function and iron overload status.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00972231


Locations
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Israel
Pediatric Hematology Unit - Ha'Emek Medical Center
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
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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
More Information
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Responsible Party: Dr Koren Ariel, Head of Pediatric Hematology Unit and Pediatric Dpt B, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT00972231    
Other Study ID Numbers: 0133-08-EMC
First Posted: September 4, 2009    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: August 2015
Keywords provided by Dr Koren Ariel, HaEmek Medical Center, Israel:
Thalassemia Major
Thalassemia Intermedia
Sickle Cell Anemia
 Sickle Cell Thalassemia
Iron Overload
Growth Velocity
Additional relevant MeSH terms:
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Anemia
Anemia, Sickle Cell
Thalassemia
Iron Overload
Hematologic Diseases
Anemia, Hemolytic, Congenital
 Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn
Iron Metabolism Disorders
Metabolic Diseases