Effect of Spirulina on Serum Hyaluronic Acid in Beta Thal... | NCT02744547

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

NCT02744547

Sponsor

Tanta University

Status

Completed

Last Update Posted

Apr 10, 2019Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Beta Thalassemia Major

Interventions

Spirulina

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015Actual

Primary Completion Date

Dec 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

Apr 16, 2016

First Submission Date that Met QC Criteria

Apr 16, 2016

First Posted Date

Apr 20, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2019

Last Update Posted Date

Apr 10, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Professor Mohamed Elshanshory, head of pediatric hematology and oncology unit, Tanta UniversityPrincipal Investigator

Lead Sponsor

Tanta UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
thalassemic children with hepatitis C	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
thalassemic children without hepatitis C	No Intervention	30 multitransfused beta thalassemic children without hepatitis C virus infection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spirulina	Dietary Supplement	Spirulina in a dose of 250 mg/kg/day will be given orally for 3 months.	thalassemic children with hepatitis C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
serum hyaluronic acid levels		3 months

Secondary Outcomes

Measure	Description	Time Frame
liver function tests		3 months
aspartate aminotransferase to platelet ratio index (APRI)		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine- Tanta University		Tanta	Gharbia Governorate	0000	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D017086	beta-Thalassemia

Ancestor Terms

ID	Term
D013789	Thalassemia
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia

Browse Leaves

Not provided

Browse Branches

Not provided