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

Sponsor

Tanta University (Other)

Overall Status

Completed

CT.gov ID

NCT02671695

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Beta Thalassemia Major	Drug: Spirulina Drug: Amlodipine	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Apr 1, 2018

Actual Study Completion Date :

Apr 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 chelation therapy plus Spirulina capsules (500 mg) in a dose of 250 mg/kg/day orally for 3 months	Drug: Spirulina Spirulina capsules (500 mg) in a dose of 250 mg/kg/day orally for 3 months
Experimental: Group 2 chelation therapy plus Amlodipine in a dose of 5 mg/day orally for 3 months	Drug: Amlodipine Amlodipine in a dose of 5 mg/day orally for 3 months

Arm

Intervention/Treatment

Experimental: Group 1

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

Drug: Spirulina

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

Experimental: Group 2

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

Drug: Amlodipine

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

Outcome Measures

Primary Outcome Measures

cardiac iron concentration by magnetic resonance imaging [3 months]

Secondary Outcome Measures

cardiac troponin 1 [3 months]
N-terminal pro-brain natriuretic peptide [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine- Tanta University	Tanta	Gharbia	Egypt	0000

Sponsors and Collaborators

Tanta University

Investigators

Principal Investigator: Sahar M El-Haggar, MD, assisstant professor of clinical pharmacy- Faculty of Pharmacy- Tanta University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Professor Mohamed Elshanshory, head of pediatric hematology and oncology unit, Tanta University

ClinicalTrials.gov Identifier:

NCT02671695

Other Study ID Numbers:

22/03/15

First Posted:

Feb 2, 2016

Last Update Posted:

Jul 12, 2018

Last Verified:

Oct 1, 2017

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 12, 2018