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GDF 15 in Sickle Cell Disease and Hereditary Spherocytosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Wolfson Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01201135
First received: September 12, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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
Patients With Thalassemia Intermedia,
Congenital Dyserythropoietic Anemia Type I

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Impact of Growth Differentiating Factor (GDF) 15 in Sickle Cell Disease and Hereditary Spherocytosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:
  • GDF 15 [ Time Frame: year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hepcidine [ Time Frame: year ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: September 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Sickle cell disease
hereditary spherocytosis.

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.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

  • non

Exclusion Criteria:

  • non
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01201135

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

Sponsors and Collaborators
Wolfson Medical Center
Investigators
Principal Investigator: GHOTI HOSSAM, doctor HEMATOLOGY DEPARTMENT ON WOLFSSON MEDICAL CENTER
  More Information

No publications provided

Responsible Party: Dr' Ghoti Hossam, hematology department on Wolfsson Medical Center
ClinicalTrials.gov Identifier: NCT01201135     History of Changes
Other Study ID Numbers: GDF-15CTIL
Study First Received: September 12, 2010
Last Updated: September 12, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anemia
Beta-Thalassemia
Anemia, Dyserythropoietic, Congenital
Anemia, Sickle Cell
Spherocytosis, Hereditary
Thalassemia
 Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 22, 2013