Effect of Spirulina Compared to Amlodipine on Cardiac Iron Overload in Children With Beta Thalassemia

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02671695

Enrollment

Registered

2016-02-02

Start date

2015-04-30

Completion date

2018-04-30

Last updated

2018-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Beta Thalassemia Major

Brief summary

the aim of this study is to evaluate the effect of Spirulina compared to Amlodipine on cardiac iron overload and cardiac functions in multi-transfused children with beta thalassemia major

Detailed description

the aim of this study is to evaluate the effect of Spirulina compared to Amlodipine on cardiac iron overload using magnetic resonance imaging and cardiac functions in multi-transfused children with beta thalassemia major

Interventions

DRUGSpirulina

Spirulina capsules (500 mg) in a dose of 250 mg/kg/day orally for 3 months

DRUGAmlodipine

Amlodipine in a dose of 5 mg/day orally for 3 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

8 Years to 18 Years

Healthy volunteers

Inclusion criteria

* patients on regular blood transfusions. * iron overload with no perspective of changing the chelation therapy in the following three months

Exclusion criteria

* formal contraindication to magnetic resonance examinations * implantable cardiac device * advanced cardiomyopathy or conduction block * other types of hemolytic anemias

Design outcomes

Primary

Measure	Time frame
cardiac iron concentration by magnetic resonance imaging	3 months

Secondary

Measure	Time frame
cardiac troponin 1	3 months
N-terminal pro-brain natriuretic peptide	3 months

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026