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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02744105
Recruitment Status : Completed
First Posted : April 20, 2016
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Professor Mohamed Elshanshory, Tanta University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Beta Thalassemia Major Dietary Supplement: Spirulina Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Spirulina on Liver Fibrosis by Transient Elastography in Beta Thalassemic Children With Hepatitis C
Actual Study Start Date : December 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Dietary Supplement: Spirulina
Spirulina in a dose of 250 mg/kg/day will be given orally for 3 months.
No Intervention: thalassemic children without hepatitis C
30 multitransfused beta thalassemic children without hepatitis C virus infection


Outcome Measures
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Primary Outcome Measures :
  1. liver stiffness measurement using transient elastography (Fibroscan) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. liver function tests [ Time Frame: 3 months ]
  2. aspartate aminotransferase to platelet ratio index (APRI) [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02744105


Locations
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Egypt
Faculty of Medicine- Tanta University
Tanta, Gharbia, Egypt, 0000
Sponsors and Collaborators
Tanta University
More Information
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Responsible Party: Professor Mohamed Elshanshory, head of pediatric hematology and oncology unit, Tanta University
ClinicalTrials.gov Identifier: NCT02744105    
Other Study ID Numbers: 2902/11/14
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Hepatitis C
Liver Cirrhosis
Thalassemia
beta-Thalassemia
Hepatitis
Liver Diseases
Digestive System Diseases
Fibrosis
Pathologic Processes
Blood-Borne Infections
Communicable Diseases
 Infections
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn