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

July 11, 2018 updated by: Professor Mohamed Elshanshory, Tanta University
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Gharbia
      • Tanta, Gharbia, Egypt, 0000
        • Faculty of Medicine- Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cardiac iron concentration by magnetic resonance imaging
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
cardiac troponin 1
Time Frame: 3 months
3 months
N-terminal pro-brain natriuretic peptide
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

January 30, 2016

First Submitted That Met QC Criteria

January 30, 2016

First Posted (Estimate)

February 2, 2016

Study Record Updates

Last Update Posted (Actual)

July 12, 2018

Last Update Submitted That Met QC Criteria

July 11, 2018

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22/03/15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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