- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02744560
Effect of Spirulina on Liver Iron Concentration in Beta Thalassemic Children With Hepatitis C
September 10, 2018 updated by: Professor Mohamed Elshanshory, Tanta University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gharbia
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Tanta, Gharbia, Egypt, 0000
- Faculty of Medicine- Tanta University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 16 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: patients
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.
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Spirulina in a dose of 250 mg/kg/day will be given orally for 3 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
liver iron concentration using magnetic resonance imaging (T2* gradient echo pulse sequence in the axial plane)
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
April 16, 2016
First Submitted That Met QC Criteria
April 16, 2016
First Posted (Estimate)
April 20, 2016
Study Record Updates
Last Update Posted (Actual)
September 11, 2018
Last Update Submitted That Met QC Criteria
September 10, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Hematologic Diseases
- Liver Diseases
- Genetic Diseases, Inborn
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Anemia
- Anemia, Hemolytic, Congenital
- Anemia, Hemolytic
- Hemoglobinopathies
- Hepatitis
- Hepatitis C
- Thalassemia
- beta-Thalassemia
Other Study ID Numbers
- 3026/01/15
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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