Beta Thalassemia Major
Conditions
Brief summary
Thalassemics can develop liver fibrosis because of iron overload and hepatitis C infection. The latter is the main risk factor for liver fibrosis in transfusion dependent thalassemics. Excess liver iron is clearly recognized as a co factor for the development of advanced fibrosis in patients with hepatitis virus C infection. Transient elastography (Fibroscan) is a reliable non invasive method for diagnosing as liver fibrosis in thalassemic patients regardless of the degree of iron overload. There is evidence that suggests Spirulina may help to protect against liver damage, cirrhosis and liver failure in those with chronic liver disease.
Interventions
DIETARY_SUPPLEMENTSpirulina
Spirulina in a dose of 250 mg/kg/day will be given orally for 3 months.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* multitransfused beta thalassemic children with and without super added hepatitis C virus (HCV) infection diagnosed by serological detection of HCV antibodies and HCV RNA by polymerase chain reaction.
Exclusion criteria
* liver decompensation child younger than 3 years patients with hepatitis B infection implantable cardiac device failure to obtain transient elastography (Fibroscan) results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| liver stiffness measurement using transient elastography (Fibroscan) | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| liver function tests | 3 months |
| aspartate aminotransferase to platelet ratio index (APRI) | 3 months |
Countries
Egypt
Outcome results
None listed