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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02744105
Date of registration: 16/04/2016
Prospective Registration: No
Primary sponsor: Tanta University
Public title: Effect of Spirulina on Liver Fibrosis by Transient Elastography in Beta Thalassemic Children With Hepatitis C
Scientific title: Effect of Spirulina on Liver Fibrosis by Transient Elastography in Beta Thalassemic Children With Hepatitis C
Date of first enrolment: December 2015
Target sample size: 60
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02744105
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Double (Care Provider, Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
Egypt
Contacts
Key inclusion & exclusion 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



Age minimum: 6 Years
Age maximum: 18 Years
Gender: All
Health Condition(s) or Problem(s) studied
Beta Thalassemia Major
Intervention(s)
Dietary Supplement: Spirulina
Primary Outcome(s)
liver stiffness measurement using transient elastography (Fibroscan) [Time Frame: 3 months]
Secondary Outcome(s)
liver function tests [Time Frame: 3 months]
aspartate aminotransferase to platelet ratio index (APRI) [Time Frame: 3 months]
Secondary ID(s)
2902/11/14
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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