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Effects of Spirulina on Cardiac Functions in Children With Beta Thalassemia Major

Primary Purpose

Beta Thalassemia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
spirulina
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Beta Thalassemia

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • children suffering from beta thalassemia major with age range from 4-18 years

Exclusion Criteria:

  • children with congenital heart diseases children with rheumatic heart diseases presence of heart failure children with coronary arterial disease children with cardiomyopathy

Sites / Locations

  • Faculty of Medicine- Tanta University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

patients

controls

Arm Description

thirty children with beta thalassemia major, with age range from 4-18 years, will receive oral spirulina (tablets=500 mg) for 3 months with a dose of 250 mg/kg/day (maximum dose 4 gm)

thirty healthy children of matched age and sex

Outcomes

Primary Outcome Measures

cardiac functions measured by echocardiography
Fractional shortening [FS]. Mitral flow early phase filling velocity [E], peak atrial phase filling velocity[A] and E/A ratio, and left ventricular (LV) diastolic function

Secondary Outcome Measures

cardiac functions measured by troponin-1 plasma level.

Full Information

First Posted
September 5, 2015
Last Updated
September 10, 2018
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT02597595
Brief Title
Effects of Spirulina on Cardiac Functions in Children With Beta Thalassemia Major
Official Title
Effects of Spirulina on Cardiac Functions in Children With Beta Thalassemia Major
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to evaluate the cardioprotective effect of spirulina in children with beta thalassemia.
Detailed Description
The aim of this study is to evaluate the cardioprotective effect of spirulina in children with beta thalassemia. this study will be carried on thirty children with beta thalassemia major from those attending the Hematology Unit of Pediatric department at Tanta University Hospital, and another thirty healthy children of matched age and sex will be enrolled as controls. all studied children will be subjected to careful history taking and through clinical examination. laboratory investigations will be done including complete blood count, hemoglobin electrophoresis, serum ferritin, liver and kidney functions, and troponin-1 plasma level. echocardiographic assessment of the cardiac functions will be done for all patients. Source data will be the patients medical records. oral spirulina will be given for studied patients for 3 months, and clinical examination, laboratory investigations and cardiac functions will be assessed at the time of inclusion in the study, and again after 3 months of regular spirulina supplementation. An informed consent will be obtained from parents of all included subjects. the results of this study will be tabulated and statistically analyzed using Statistical Package for the Social Sciences (SPSS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Beta Thalassemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients
Arm Type
Experimental
Arm Description
thirty children with beta thalassemia major, with age range from 4-18 years, will receive oral spirulina (tablets=500 mg) for 3 months with a dose of 250 mg/kg/day (maximum dose 4 gm)
Arm Title
controls
Arm Type
No Intervention
Arm Description
thirty healthy children of matched age and sex
Intervention Type
Other
Intervention Name(s)
spirulina
Intervention Description
oral spirulina (tablet=500mg) will be given to patients for 3 months in a dose of 250 mg/kg/day (maximum 4 gm)
Primary Outcome Measure Information:
Title
cardiac functions measured by echocardiography
Description
Fractional shortening [FS]. Mitral flow early phase filling velocity [E], peak atrial phase filling velocity[A] and E/A ratio, and left ventricular (LV) diastolic function
Time Frame
after 3 months of regular oral spirulina supplementation
Secondary Outcome Measure Information:
Title
cardiac functions measured by troponin-1 plasma level.
Time Frame
after 3 months of regular oral spirulina supplementation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: children suffering from beta thalassemia major with age range from 4-18 years Exclusion Criteria: children with congenital heart diseases children with rheumatic heart diseases presence of heart failure children with coronary arterial disease children with cardiomyopathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magda M Ibrahim, M.B.B.ch
Organizational Affiliation
Master Degree student
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Osama AR Tolba, MD
Organizational Affiliation
supervisor
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rasha M Gamal, MD
Organizational Affiliation
supervisor
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Medicine- Tanta University
City
Tanta
State/Province
Gharbia
ZIP/Postal Code
0000
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
16372368
Citation
Khan M, Shobha JC, Mohan IK, Naidu MU, Sundaram C, Singh S, Kuppusamy P, Kutala VK. Protective effect of Spirulina against doxorubicin-induced cardiotoxicity. Phytother Res. 2005 Dec;19(12):1030-7. doi: 10.1002/ptr.1783.
Results Reference
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PubMed Identifier
18404006
Citation
Cogliandro T, Derchi G, Mancuso L, Mayer MC, Pannone B, Pepe A, Pili M, Bina P, Cianciulli P, De Sanctis V, Maggio A; Society for the Study of Thalassemia and Hemoglobinopathies (SoSTE). Guideline recommendations for heart complications in thalassemia major. J Cardiovasc Med (Hagerstown). 2008 May;9(5):515-25. doi: 10.2459/JCM.0b013e3282f20847.
Results Reference
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PubMed Identifier
23775258
Citation
Pennell DJ, Udelson JE, Arai AE, Bozkurt B, Cohen AR, Galanello R, Hoffman TM, Kiernan MS, Lerakis S, Piga A, Porter JB, Walker JM, Wood J; American Heart Association Committee on Heart Failure and Transplantation of the Council on Clinical Cardiology and Council on Cardiovascular Radiology and Imaging. Cardiovascular function and treatment in beta-thalassemia major: a consensus statement from the American Heart Association. Circulation. 2013 Jul 16;128(3):281-308. doi: 10.1161/CIR.0b013e31829b2be6. Epub 2013 Jun 17. Erratum In: Circulation. 2013 Sep 24;128(13):e203.
Results Reference
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Effects of Spirulina on Cardiac Functions in Children With Beta Thalassemia Major

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