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Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia

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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

Tracking Information
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
 (submitted: July 16, 2013)
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
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00972231 on ClinicalTrials.gov Archive Site
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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
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
  • Thalassemia
  • Sickle Cell Disease
Intervention Other: Medical Chart Summary
Summary of the Medical Files including annual growth velocity, endocrine function and iron overload status.
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 30, 2015)
93
Original Estimated Enrollment
 (submitted: September 3, 2009)
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:

  • 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.
Sex/Gender
Sexes Eligible for Study: All
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
Responsible Party Dr Koren Ariel, HaEmek Medical Center, Israel
Study Sponsor HaEmek Medical Center, Israel
Collaborators Not Provided
Investigators
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
PRS Account HaEmek Medical Center, Israel
Verification Date August 2015