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

Primary Purpose

Beta Thalassemia Major

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Spirulina
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Beta Thalassemia Major

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine- Tanta University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

thalassemic children with hepatitis C

thalassemic children without hepatitis C

Arm Description

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.

30 multitransfused beta thalassemic children without hepatitis C virus infection

Outcomes

Primary Outcome Measures

liver stiffness measurement using transient elastography (Fibroscan)

Secondary Outcome Measures

liver function tests
aspartate aminotransferase to platelet ratio index (APRI)

Full Information

First Posted
April 16, 2016
Last Updated
September 10, 2018
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT02744105
Brief Title
Effect of Spirulina on Liver Fibrosis by Transient Elastography in Beta Thalassemic Children With Hepatitis C
Official Title
Effect of Spirulina on Liver Fibrosis by Transient Elastography in Beta Thalassemic Children With Hepatitis C
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Beta Thalassemia Major

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
thalassemic children with hepatitis C
Arm Type
Experimental
Arm Description
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.
Arm Title
thalassemic children without hepatitis C
Arm Type
No Intervention
Arm Description
30 multitransfused beta thalassemic children without hepatitis C virus infection
Intervention Type
Dietary Supplement
Intervention Name(s)
Spirulina
Intervention Description
Spirulina in a dose of 250 mg/kg/day will be given orally for 3 months.
Primary Outcome Measure Information:
Title
liver stiffness measurement using transient elastography (Fibroscan)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
liver function tests
Time Frame
3 months
Title
aspartate aminotransferase to platelet ratio index (APRI)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Faculty of Medicine- Tanta University
City
Tanta
State/Province
Gharbia
ZIP/Postal Code
0000
Country
Egypt

12. IPD Sharing Statement

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

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