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

• Sponsor: Tanta University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02744547
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 24
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Beta Thalassemia Major	Dietary Supplement: Spirulina	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Effect of Spirulina on Serum Hyaluronic Acid as a Marker for Liver Fibrosis in Beta Thalassemic Children With Hepatitis C
• Actual Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: thalassemic children with hepatitis C 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.	Dietary Supplement: Spirulina; Spirulina in a dose of 250 mg/kg/day will be given orally for 3 months.
No Intervention: thalassemic children without hepatitis C 30 multitransfused beta thalassemic children without hepatitis C virus infection

Outcome Measures

Primary Outcome Measures

1. serum hyaluronic acid levels [3 months]

Secondary Outcome Measures

1. liver function tests [3 months]

2. aspartate aminotransferase to platelet ratio index (APRI) [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine- Tanta University	Tanta	Gharbia	Egypt	0000

Sponsors and Collaborators

• Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Professor Mohamed Elshanshory, head of pediatric hematology and oncology unit, Tanta University
• ClinicalTrials.gov Identifier: NCT02744547
• Other Study ID Numbers: 2900/11/14
• First Posted: Apr 20, 2016
• Last Update Posted: Apr 10, 2019
• Last Verified: Apr 1, 2019

• Additional relevant MeSH terms: Hepatitis C; Thalassemia; beta-Thalassemia

Study Results

No Results Posted as of Apr 10, 2019