Back to resultsEffect of Spirulina on Liver Iron Concentration 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 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 contraindications to perform MRI (intraocular metallic foreign body, cardiac pacemaker, intracranial clips of arterial brain aneurysms) refusal to participate in the study
Sites / Locations
- Faculty of Medicine- Tanta University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients
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.
Outcomes
Primary Outcome Measures
liver iron concentration using magnetic resonance imaging (T2* gradient echo pulse sequence in the axial plane)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02744560
Brief Title
Effect of Spirulina on Liver Iron Concentration in Beta Thalassemic Children With Hepatitis C
Official Title
Effect of Spirulina on Liver Iron Concentration 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
March 2015 (undefined)
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
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. Magnetic resonance imaging represents the most available noninvasive technique to assess the level of iron in the liver.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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients
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.
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 iron concentration using magnetic resonance imaging (T2* gradient echo pulse sequence in the axial plane)
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 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 contraindications to perform MRI (intraocular metallic foreign body, cardiac pacemaker, intracranial clips of arterial brain aneurysms) refusal to participate in the study
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 Iron Concentration in Beta Thalassemic Children With Hepatitis C
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