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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Double (Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: December 2017

Interventions

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

Arms, Groups and Cohorts

  • Experimental: thalassemic children with hepatitis C
    • 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.
  • No Intervention: thalassemic children without hepatitis C
    • 30 multitransfused beta thalassemic children without hepatitis C virus infection

Clinical Trial Outcome Measures

Primary Measures

  • liver stiffness measurement using transient elastography (Fibroscan)
    • Time Frame: 3 months

Secondary Measures

  • liver function tests
    • Time Frame: 3 months
  • aspartate aminotransferase to platelet ratio index (APRI)
    • Time Frame: 3 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tanta University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Professor Mohamed Elshanshory, head of pediatric hematology and oncology unit – Tanta University

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