GDF 15 in Sickle Cell Disease and Hereditary Spherocytosis

Congenital Dyserythropoietic Anemia Type I Clinical Trial

— GDF 15  

Official title:

The Impact of Growth Differentiating Factor (GDF) 15 in Sickle Cell Disease and Hereditary Spherocytosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01201135
• Other study ID #: GDF-15CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: September 12, 2010
• Last updated: September 12, 2010
• Start date: September 2010
• Est. completion date: September 2011

Study information

• Verified date: September 2010
• Source: Wolfson Medical Center
• Contact: Ghoti Hossam, doctor
• Phone: 035028110
• Email: drghoti123[@]yahoo.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Patients with thalassemia intermedia, congenital dyserythropoietic anemia type I , and sideroblastic anemia were found to express very high levels of serum GDF15, and this contributed to the inappropriate suppression of hepcidin with subsequent secondary iron overload.The aim of our present study is to asses the levels of GDF15 and hepcidin in patients with Sickle cell disease and hereditary spherocytosis

Description:

The identification of the ferroportin/hepcidin axis has allowed the effect of erythroid activity on iron balance to be studied and has created the basis for better defining the erythroid regulators.

In iron-loading anemias, ineffective erythropoiesis suppresses hepcidin production, which result in dysregulating iron homeostasis. Miller and co-workers showed that release of cytokines like growth differentiation factor 15 (GDF15) during the process of ineffective erythropoiesis inhibits hepcidin production, thus defining a molecular link between ineffective erythropoiesis, suppression of hepcidin production and parenchymal iron loading.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

• non

Exclusion Criteria:

• non

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Beta-Thalassemia
• Congenital Dyserythropoietic Anemia Type I
• Patients With Thalassemia Intermedia,
• Thalassemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GDF 15		year	No
Secondary	Hepcidine		year	No