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GDF 15 in Sickle Cell Disease and Hereditary Spherocytosis (GDF 15)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01201135
Recruitment Status : Unknown
Verified September 2010 by Wolfson Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : September 14, 2010
Last Update Posted : September 14, 2010
Information provided by:
Wolfson Medical Center

Brief 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

Condition or disease
Patients With Thalassemia Intermedia, Congenital Dyserythropoietic Anemia Type I

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 80 participants
Time Perspective: Prospective
Official Title: The Impact of Growth Differentiating Factor (GDF) 15 in Sickle Cell Disease and Hereditary Spherocytosis
Study Start Date : September 2010
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011

Sickle cell disease
hereditary spherocytosis.

Primary Outcome Measures :
  1. GDF 15 [ Time Frame: year ]

Secondary Outcome Measures :
  1. Hepcidine [ Time Frame: year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study will contain 40 patients with Sickle cell disease and 40 patients with hereditary spherocytosis.

After ICF (Informed Consent Form) has been signed by the patients the following laboratory tests will be taken once during the study:

  1. GDF 15( 3ml of serum) (at the laboratory of hematology at Wolfson Medical Center/Israel)
  2. Hepcidine (3ml of serum) (at the laboratory of Prof. T. Ganz, USA). The blood samples should be taken at least one week apart from blood transfusion.

In case of infection or acute inflammation , blood samples should be taken only one week after resolution of these conditions.


Inclusion Criteria:

  • non

Exclusion Criteria:

  • non

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01201135

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Contact: Ghoti Hossam, doctor 035028110 drghoti123@yahoo.com

Sponsors and Collaborators
Wolfson Medical Center
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Responsible Party: Dr' Ghoti Hossam, hematology department on Wolfsson Medical Center
ClinicalTrials.gov Identifier: NCT01201135    
Other Study ID Numbers: GDF-15CTIL
First Posted: September 14, 2010    Key Record Dates
Last Update Posted: September 14, 2010
Last Verified: September 2010
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Spherocytosis, Hereditary
Anemia, Dyserythropoietic, Congenital
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn