Effect of Spirulina on Serum Hyaluronic Acid in Beta Thalassemic Children With Hepatitis C
1 other identifier
interventional
60
1 country
1
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 16, 2016
CompletedFirst Posted
Study publicly available on registry
April 20, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedApril 10, 2019
April 1, 2019
2 years
April 16, 2016
April 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
serum hyaluronic acid levels
3 months
Secondary Outcomes (2)
liver function tests
3 months
aspartate aminotransferase to platelet ratio index (APRI)
3 months
Study Arms (2)
thalassemic children with hepatitis C
EXPERIMENTAL30 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.
thalassemic children without hepatitis C
NO INTERVENTION30 multitransfused beta thalassemic children without hepatitis C virus infection
Interventions
Spirulina in a dose of 250 mg/kg/day will be given orally for 3 months.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- liver decompensation child younger than 3 years patients with hepatitis B infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Faculty of Medicine- Tanta University
Tanta, Gharbia Governorate, 0000, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- head of pediatric hematology and oncology unit
Study Record Dates
First Submitted
April 16, 2016
First Posted
April 20, 2016
Study Start
December 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
April 10, 2019
Record last verified: 2019-04