Beta Thalassemia Major, Liver Fibrosis
Conditions
Keywords
Fibroscan, Liver fibrosis, Iron overload, Beta- thalassemia
Brief summary
The goal of this cross-sectional observational study is to evaluate the accuracy of serum ferritin and serum hepcidin versus non-invasive scores in the diagnosis of liver fibrosis and iron overload in beta- thalassemia children. Researchers will measure and correlate serum ferritin, hepcidin and hepcidin/ferritin ratio in beta- thalassemia children with liver fibrosis. Researchers will also evaluate the performance of serum ferritin, hepcidin and hepcidin/ferritin ratio, AST to platelet ratio index (APRI) score, and fibrosis-4 (FIB-4) score, for predicting significant fibrosis (\>=F2). Participants will undergo history-taking, clinical examination, laboratory investigations, serum ferritin, serum hepcidin, abdominal ultrasonography, and Fibroscan examination. The APRI, FIB-4, and hepcidin/ferritin ratio will be calculated. The performance of serum ferritin, hepcidin and hepcidin/ferritin ratio for predicting significant fibrosis will be compared versus other non-invasive scores.
Interventions
DIAGNOSTIC_TESTSerum ferritin
Serum ferritin is a protein that stores iron, and high serum ferritin levels can suggest iron overload, but are also a common indicator of other conditions like inflammation, liver disease, or metabolic syndrome.
DIAGNOSTIC_TESTSerum hepcidin
Hepcidin hormone has been found to be a key regulator of iron homeostasis. It controls plasma iron levels by regulating two key steps in iron metabolism, namely digestive iron absorption in enterocytes and iron recycling in macrophages. Hepcidin is synthesized predominantly in the hepatocytes, which is physiologically increased by elevated serum iron level and decreased by erythropoietic activity. Recently, hepcidin has been used as a new marker for evaluation of liver fibrosis in patients with thalassemia major.
Sponsors
Tanta University
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Children with ß-thalassemia major * iron overload, as indicated by serum ferritin levels more than 500 ng/mL.
Exclusion criteria
* Pediatric patients with liver diseases (such as hepatitis). * children with other types of chronic hemolytic anemia. * other chronic systemic diseases (DM and Hypertension) or malignancy or heart diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| measuring hepcidin level (nanogram/ml) for predicting iron overload | through study completion, an average 6 months |
| measuring ferritin level (nanogram/ml) for predicting significant fibrosis | through study completion, an average 6 months |
| measuring hepcidin level (nanogram/ml) for predicting significant fibrosis | through study completion, an average of 6 months |
Secondary
| Measure | Time frame |
|---|---|
| comparing serum ferritin versus non-invasive scores for significant fibrosis | through study completion, an average of 6 months |
| comparing serum hepcidin versus non-invasive scores for significant fibrosis | through study completion, an average of 6 months |
Countries
Egypt
Outcome results
None listed