Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by HaEmek Medical Center, Israel
Sponsor:
Information provided by (Responsible Party):
Dr Koren Ariel, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00972231
First received: September 3, 2009
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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 Intervention
Thalassemia
Sickle Cell Disease
Other: Medical Chart Summary

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 150
Study Start Date: January 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   5 Years to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972231

Contacts
Contact: Ariel Koren, MD 972-4-6495576 ext 5576 koren_a@clalit.org.il

Locations
Israel
Pediatric Hematology Unit - Ha'Emek Medical Center Recruiting
Afula, Israel, 18101
Contact: Ariel Koren, MD    972-4-6495576 ext 5576    koren_a@clalit.org.il   
Principal Investigator: Ariel Koren, MD         
Sub-Investigator: Carina Levin, MD         
Sponsors and Collaborators
HaEmek Medical Center, Israel
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
  More Information

No publications provided

Responsible Party: Dr Koren Ariel, Head of Pediatric Hematology Unit and Pediatric Dpt B, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT00972231     History of Changes
Other Study ID Numbers: 0133-08-EMC
Study First Received: September 3, 2009
Last Updated: July 16, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by HaEmek Medical Center, Israel:
Thalassemia Major
Thalassemia Intermedia
Sickle Cell Anemia
Sickle Cell Thalassemia
Iron Overload
Growth Velocity

Additional relevant MeSH terms:
Anemia
Anemia, Sickle Cell
Thalassemia
Iron Overload
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014