Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia

August 30, 2015 updated by: Dr Koren Ariel, HaEmek Medical Center, Israel

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

93

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel, 18101
        • Pediatric Hematology Unit - Ha'Emek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia
Time Frame: One year
Analysis of Growth Velocity in Thalassemia and Sickle Cell Anemia and correlation with Iron Overload
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 3, 2009

First Submitted That Met QC Criteria

September 3, 2009

First Posted (Estimate)

September 4, 2009

Study Record Updates

Last Update Posted (Estimate)

September 1, 2015

Last Update Submitted That Met QC Criteria

August 30, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0133-08-EMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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