Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia

Sickle Cell Disease Clinical Trial

Official title:

Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00972231
• Other study ID #: 0133-08-EMC
• Status: Completed
• Phase: N/A
• First received: September 3, 2009
• Last updated: August 30, 2015
• Start date: January 2009
• Est. completion date: December 2010

Study information

• Verified date: August 2015
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 45 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Iron Overload
• Sickle Cell Disease
• Thalassemia

Intervention

Other:
• Medical Chart Summary
Summary of the Medical Files including annual growth velocity, endocrine function and iron overload status.

Locations

Country	Name	City	State
Israel	Pediatric Hematology Unit - Ha'Emek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia	Analysis of Growth Velocity in Thalassemia and Sickle Cell Anemia and correlation with Iron Overload	One year	No