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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2018-04-30

Brief Summary

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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

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Detailed Description

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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

Conditions

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Beta Thalassemia Major

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Group 1

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

Group Type EXPERIMENTAL

Spirulina

Intervention Type DRUG

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

Group 2

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

Group Type EXPERIMENTAL

Amlodipine

Intervention Type DRUG

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

Interventions

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Spirulina

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

Intervention Type DRUG

Amlodipine

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No