Iron Overload Clinical Trial
Official title:
Assessment of Iron Deposition in Major Organs of Hemodialysis Patients, Using T2*MRI and Novel Biomarkers of Free Iron Species
The purpose of the present study is to evaluate in hemodialysis patients, who have elevated
serum ferritin ( >2000ng/ml) and transferrin saturation (TSAT) >30%, iron deposition in the
heart, pancreas, liver and spleen using the T2* MRI technique.
In addition, we will also measure the free iron forms in the plasma and LPI, LCI in red
blood cells, platelets and PMN, in addition to serum hepcidin, TSAT, serum ferritin, CRP and
oxidative stress parameters (ROS,GSH, and malonyldialdehyde (MDA).
Status | Recruiting |
Enrollment | 20 |
Est. completion date | August 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - patients for study are > 50 years of age, - on chronic hemodialysis for at least one year, - with serum ferritin levels > 2000 ng/ml and TSAT > 30%. Exclusion Criteria: - malignancies, - any active infection requiring systemic antibiotic therapy, and - hospitalization within the two weeks before screening. |
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Israel | Wolfsson Medical Center | Holon |
Lead Sponsor | Collaborator |
---|---|
Wolfson Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | T2*MRI (magnetic resonance imaging) | This method is commonly used to evaluate and monitor iron deposition in major organs (iron overload) in hemodialysis patients with end stage renal failure | one year | No |
Secondary | Iron parameters (FERRITIN, TRANSFERREN SAT ,LPI HEPCIDIN,LCI,CRP,OXIDATIVE STRESS PARAMETERS(ROS,GSH,MDA) | we will also measure the free iron forms in the plasma and LPI, LCI in red blood cells, platelets and PMN, in addition to serum hepcidin, TSAT, serum ferritin, CRP and oxidative stress parameters (ROS,GSH, and malonyldialdehyde (MDA). | ONE YEAR | No |
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