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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00972231
Other study ID # 0133-08-EMC
Secondary ID
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


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
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