Iron Overload and Growth Velocity in Thalassemia and Sickle Cell Anemia

NCT00972231 | Completed

• 1 other identifier: 0133-08-EMC
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Thalassemia; Sickle Cell Disease

Keywords

Thalassemia Major; Thalassemia Intermedia; Sickle Cell Anemia; Sickle Cell Thalassemia; Iron Overload; Growth Velocity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Thalassemia Group

Patients suffering from Thalassemia Major and patients with Thalassemia Intermedia

Other: Medical Chart Summary

Sickle Cell Group

Patients with Sickle Cell Anemia and Sickle Cell Thalassemia

Other: Medical Chart Summary

Interventions

Medical Chart Summary OTHER

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

Sickle Cell Group; Thalassemia Group

Eligibility Criteria

• Age: 5 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• All patients in follow up with available medical charts.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Pediatric Hematology Unit - Ha'Emek Medical Center

Afula, Afula, 18101, Israel

Location

MeSH Terms

Conditions

Thalassemia; Anemia, Sickle Cell; beta-Thalassemia; Iron Overload

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pediatric Hematology Unit and Pediatric Dpt B

Study Record Dates

• First Submitted: September 3, 2009
• First Posted: September 4, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: September 1, 2015

Record last verified: 2015-08

Locations

IL (1)