Effect of Spirulina on Liver Fibrosis by Transient Elastography in Beta Thalassemic Children With Hepatitis C

Beta Thalassemia Major Clinical Trial

Official title:

Effect of Spirulina on Liver Fibrosis by Transient Elastography in Beta Thalassemic Children With Hepatitis C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02744105
• Other study ID #: 2902/11/14
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 2017

Study information

• Verified date: September 2018
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Beta Thalassemia Major
• beta-Thalassemia
• Hepatitis C
• Liver Cirrhosis
• Thalassemia

Intervention

Dietary Supplement:
• Spirulina
Spirulina in a dose of 250 mg/kg/day will be given orally for 3 months.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine- Tanta University	Tanta	Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	liver stiffness measurement using transient elastography (Fibroscan)		3 months
Secondary	liver function tests		3 months
Secondary	aspartate aminotransferase to platelet ratio index (APRI)		3 months