Effect of Spirulina on Liver Iron Concentration in Beta Thalassemic Children With Hepatitis C

NCT ID: NCT02744560

Last Updated: 2018-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-12-31

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. Magnetic resonance imaging represents the most available noninvasive technique to assess the level of iron in the liver.there is evidence that suggests Spirulina may help to protect against liver damage, cirrhosis and liver failure in those with chronic liver disease.

Conditions

Beta Thalassemia Major

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

patients

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.

Group Type: EXPERIMENTAL

spirulina

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

spirulina

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• multitransfused beta thalassemic children with 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 contraindications to perform MRI (intraocular metallic foreign body, cardiac pacemaker, intracranial clips of arterial brain aneurysms) refusal to participate in the study

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Professor Mohamed Elshanshory

head of pediatric hematology and oncology unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine- Tanta University

Tanta, Gharbia Governorate, Egypt

Countries

Egypt

Other Identifiers

3026/01/15

Identifier Type: -

Identifier Source: org_study_id