Clinical trial NCT00972231: Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia
Official title: Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thalassemia
Sickle Cell Disease
Keywords: Thalassemia Major
Thalassemia Intermedia
Sickle Cell Anemia
Sickle Cell Thalassemia
Iron Overload
Growth Velocity
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2009-09-04
Enrollment: 93
Sex: ALL
Minimum age (years): 5
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Pediatric Hematology Unit - Ha'Emek Medical Center
Study officials:
affiliation: Pediatric Dpt B and Pediatric Hemaology Unit - Ha'Emek Medical Center - Afula - Israel
name: Ariel Koren, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pediatric Hematology Unit, Ha'Emek Medical Center, Afula, Israel
name: Carina Levin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pediatic Hematology Unit, Ha'Emek Medical Center, Afula, Israel
name: Daniela Mathov, Student
role: PRINCIPAL_INVESTIGATOR
References: