Clinical trial NCT02597595: 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
Overall status: COMPLETED
Phase: NA
Conditions: Beta Thalassemia
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2015-11-05
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: cardiac functions measured by echocardiography
timeFrame: after 3 months of regular oral spirulina supplementation
Secondary outcomes:
measure: cardiac functions measured by troponin-1 plasma level.
timeFrame: after 3 months of regular oral spirulina supplementation
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Medicine- Tanta University
state: Gharbia
Study officials:
affiliation: Master Degree student
name: Magda M Ibrahim, M.B.B.ch
role: PRINCIPAL_INVESTIGATOR
affiliation: supervisor
name: Osama AR Tolba, MD
role: STUDY_CHAIR
affiliation: supervisor
name: Rasha M Gamal, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.