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

Sponsor

Tanta University (Other)

Overall Status

Completed

CT.gov ID

NCT02744560

Collaborator

(none)

Enrollment

Location

Arm

33.1

Duration (Months)

0.9

Patients Per Site Per Month

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. 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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Dietary Supplement: spirulina Spirulina in a dose of 250 mg/kg/day will be given orally for 3 months.

Arm

Intervention/Treatment

Experimental: 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.

Dietary Supplement: spirulina

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

Outcome Measures

Primary Outcome Measures

liver iron concentration using magnetic resonance imaging (T2* gradient echo pulse sequence in the axial plane) [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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:

NCT02744560

Other Study ID Numbers:

3026/01/15

First Posted:

Apr 20, 2016

Last Update Posted:

Sep 11, 2018

Last Verified:

Sep 1, 2018

Additional relevant MeSH terms:

Hepatitis C

Thalassemia

beta-Thalassemia

Study Results

No Results Posted as of Sep 11, 2018