Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia

Sponsor

HaEmek Medical Center, Israel (Other)

Overall Status

Completed

CT.gov ID

NCT00972231

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

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 :

Jan 1, 2009

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	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.

Arm

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

Primary Outcome Measures

Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia [One year]
Analysis of Growth Velocity in Thalassemia and Sickle Cell Anemia and correlation with Iron Overload

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Pediatric Hematology Unit - Ha'Emek Medical Center	Afula		Israel	18101

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