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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02671695
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Professor Mohamed Elshanshory, Tanta University

Tracking Information
First Submitted Date  ICMJE January 30, 2016
First Posted Date  ICMJE February 2, 2016
Last Update Posted Date July 12, 2018
Study Start Date  ICMJE April 2015
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2016)
cardiac iron concentration by magnetic resonance imaging [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2016)
  • cardiac troponin 1 [ Time Frame: 3 months ]
  • N-terminal pro-brain natriuretic peptide [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Spirulina Compared to Amlodipine on Cardiac Iron Overload in Children With Beta Thalassemia
Official Title  ICMJE Effect of Spirulina Compared to Amlodipine on Cardiac Iron Overload in Children With Beta Thalassemia
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Beta Thalassemia Major
Intervention  ICMJE
  • Drug: Spirulina
    Spirulina capsules (500 mg) in a dose of 250 mg/kg/day orally for 3 months
  • Drug: Amlodipine
    Amlodipine in a dose of 5 mg/day orally for 3 months
Study Arms  ICMJE
  • Experimental: Group 1
    chelation therapy plus Spirulina capsules (500 mg) in a dose of 250 mg/kg/day orally for 3 months
    Intervention: Drug: Spirulina
  • Experimental: Group 2
    chelation therapy plus Amlodipine in a dose of 5 mg/day orally for 3 months
    Intervention: Drug: Amlodipine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 30, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2018
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02671695
Other Study ID Numbers  ICMJE 22/03/15
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor Mohamed Elshanshory, Tanta University
Study Sponsor  ICMJE Tanta University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sahar M El-Haggar, MD assisstant professor of clinical pharmacy- Faculty of Pharmacy- Tanta University
PRS Account Tanta University
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP