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

NCT02744560 | Completed

• 1 other identifier: 3026/01/15
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 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. 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

Outcome Measures

Primary Outcomes (1)

• liver iron concentration using magnetic resonance imaging (T2* gradient echo pulse sequence in the axial plane)

  3 months

Study Arms (1)

patients

EXPERIMENTAL

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

Interventions

spirulina DIETARY_SUPPLEMENT

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

patients

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Medicine- Tanta University

Tanta, Gharbia Governorate, 0000, Egypt

Location

MeSH Terms

Conditions

beta-Thalassemia

Condition Hierarchy (Ancestors)

Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• 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: March 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 11, 2018

Record last verified: 2018-09

Locations

EG (1)