Back to resultsEffect of Spirulina on Serum Hyaluronic Acid 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
About this trial
This is an interventional supportive care trial for Beta Thalassemia Major
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
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
serum hyaluronic acid levels
Secondary Outcome Measures
liver function tests
aspartate aminotransferase to platelet ratio index (APRI)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02744547
Brief Title
Effect of Spirulina on Serum Hyaluronic Acid in Beta Thalassemic Children With Hepatitis C
Official Title
Effect of Spirulina on Serum Hyaluronic Acid as a Marker for Liver Fibrosis in Beta Thalassemic Children With Hepatitis C
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
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. Hyaluronic acid serum levels correlate with histological stages of liver fibrosis in hepatitis C patients, so it has a good diagnostic accuracy as a non invasive assessment of fibrosis and cirrhosis.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
serum hyaluronic acid levels
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
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 Serum Hyaluronic Acid in Beta Thalassemic Children With Hepatitis C
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