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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02744547
Other study ID # 2900/11/14
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2015
Est. completion date December 2017

Study information

Verified date April 2019
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility 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

Study Design


Intervention

Dietary Supplement:
Spirulina
Spirulina in a dose of 250 mg/kg/day will be given orally for 3 months.

Locations

Country Name City State
Egypt Faculty of Medicine- Tanta University Tanta Gharbia

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary serum hyaluronic acid levels 3 months
Secondary liver function tests 3 months
Secondary aspartate aminotransferase to platelet ratio index (APRI) 3 months
See also
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Completed NCT02671695 - Effect of Spirulina Compared to Amlodipine on Cardiac Iron Overload in Children With Beta Thalassemia N/A
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