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

NCT02597595 | Completed DMC

• 1 other identifier: 2771/09/14
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the cardioprotective effect of spirulina in children with beta thalassemia.

Conditions

Beta Thalassemia

Outcome Measures

Primary Outcomes (1)

• 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

  after 3 months of regular oral spirulina supplementation

Secondary Outcomes (1)

• cardiac functions measured by troponin-1 plasma level.

  after 3 months of regular oral spirulina supplementation

Study Arms (2)

patients

EXPERIMENTAL

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)

Other: spirulina

controls

NO INTERVENTION

thirty healthy children of matched age and sex

Interventions

spirulina OTHER

oral spirulina (tablet=500mg) will be given to patients for 3 months in a dose of 250 mg/kg/day (maximum 4 gm)

patients

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Medicine- Tanta University

Tanta, Gharbia Governorate, 0000, Egypt

Location

Related Publications (3)

• 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.

  PMID: 16372368 BACKGROUND

• 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.

  PMID: 18404006 BACKGROUND

• 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.

  PMID: 23775258 BACKGROUND

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 Officials

• Magda M Ibrahim, M.B.B.ch

  Master Degree student

  PRINCIPAL INVESTIGATOR

• Osama AR Tolba, MD

  supervisor

  STUDY CHAIR

• Rasha M Gamal, MD

  supervisor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor and head of hematology and oncology unit at pediatric department

Study Record Dates

• First Submitted: September 5, 2015
• First Posted: November 5, 2015
• Study Start: November 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: September 11, 2018

Record last verified: 2018-09

Locations

EG (1)