Clinical and Laboratory Assessment of Iron Overload in Sickle Cell Anemia and Sickle Cell Thalassemia

Sickle Cell Anemia Clinical Trial

Official title:

Clinical and Laboratory Assessment of Iron Overload in Sickle Cell Anemia and Sickle Cell Thalassemia - An Observational and Laboratory Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00512564
• Other study ID #: 0087-07-EMC
• Status: Completed
• Phase: N/A
• First received: August 5, 2007
• Last updated: August 25, 2011
• Start date: September 2008
• Est. completion date: December 2010

Study information

• Verified date: August 2011
• 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 is well study in Thalassemia patients and it's not only related to blood transfusions, since intestinal iron absorption is also increased in those patients. Sickle cell patients didn't developed significant clinical symptoms and signs of iron overload in spite frequent transfusions. The purpose of this study is to assess the iron overload in Sickle cell anemia and Sickle cell Thalassemia patients using clinical parameters and laboratory studies including Non Transferrin Binding Iron, Labile Iron and Hepcidin, in order to determine the cardiac and liver iron.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All the patients with Sickle Cell Anemia and Sickle Cell Thalassemia that are treated and followed up at the Pediatric Hematology Unit.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia
• Anemia, Sickle Cell
• Iron Overload
• Sickle Cell Anemia
• Sickle Cell Thalassemia
• Thalassemia

Intervention

Other:
• Laboratory analyses of iron overload
Summary of clinical status related to iron overload and laboratory analysis of Iron overload including Total serum Iron, Transferrin, Ferritin and Non transferrin Binding Iron and Labile Plasma Iron

Locations

Country	Name	City	State
Israel	Pediatric Hematology Unit - HaEmek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel,