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

Not Applicable

Completed

• Conditions: Beta Thalassemia Major
• Interventions: Dietary Supplement: Spirulina

• Registration Number: NCT02744105
• Lead Sponsor: Tanta University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-04-16
• Study First Submitted QC: 2016-04-19
• Study First Posted: 2016-04-20
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-10
• Last Update Posted: 2018-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
thalassemic children with hepatitis C	Spirulina	30 multitransfused beta thalassemic children infected with hepatitis C virus diagnosed by serological detection of HCV-antibodies and HCV RNA by polymerase chain reaction will be given Spirulina in a dose of 250 mg/kg/day orally for 3 months.

Primary Outcome Measures

Name	Time	Method
liver stiffness measurement using transient elastography (Fibroscan)	3 months

Secondary Outcome Measures

Name	Time	Method
liver function tests	3 months
aspartate aminotransferase to platelet ratio index (APRI)	3 months

Trial Locations

Locations (1)

Faculty of Medicine- Tanta University; 🇪🇬 Tanta, Gharbia, Egypt