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Completed

NCT Number: NCT02744547

Effect of Spirulina on Serum Hyaluronic Acid in Beta Thalassemic Children With Hepatitis C

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.

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Key information

Conditions

Beta Thalassemia Major Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Thalassemia beta-Thalassemia

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine- Tanta University

Tanta, Gharbia Governorate, 0000, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spirulina

Dietary Supplement

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

Primary outcomes

  1. serum hyaluronic acid levels

    Time frame: 3 months

Secondary outcomes

  1. liver function tests

    Time frame: 3 months

  2. aspartate aminotransferase to platelet ratio index (APRI)

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Effect of Spirulina on Serum Hyaluronic Acid as a Marker for Liver Fibrosis in Beta Thalassemic Children With Hepatitis C

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 20, 2016
Registry last updated
Apr 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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