Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia

NCT ID: NCT00972231

Last Updated: 2015-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

93 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Thalassemia Sickle Cell Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Thalassemia Group

Patients suffering from Thalassemia Major and patients with Thalassemia Intermedia

Medical Chart Summary

Intervention Type OTHER

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

Medical Chart Summary

Intervention Type OTHER

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

Interventions

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Medical Chart Summary

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Dr Koren Ariel

Head of Pediatric Hematology Unit and Pediatric Dpt B

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ariel Koren, MD

Role: PRINCIPAL_INVESTIGATOR

Pediatric Dpt B and Pediatric Hemaology Unit - Ha'Emek Medical Center - Afula - Israel

Carina Levin, MD

Role: PRINCIPAL_INVESTIGATOR

Pediatric Hematology Unit, Ha'Emek Medical Center, Afula, Israel

Daniela Mathov, Student

Role: PRINCIPAL_INVESTIGATOR

Pediatic Hematology Unit, Ha'Emek Medical Center, Afula, Israel

Locations

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Pediatric Hematology Unit - Ha'Emek Medical Center

Afula, Afula, Israel

Site Status

Countries

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Israel

Other Identifiers

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0133-08-EMC

Identifier Type: -

Identifier Source: org_study_id

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