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the Potential Immunomodulatory Effects of Spirulina on Thalassemic Children

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: NCT02674607
Recruitment Status : Completed
First Posted : February 4, 2016
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
Professor Mohamed Elshanshory, Tanta University

Study Description
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Brief Summary:
The aim of this study is to evaluate the possible immunologic effects of spirulina in children with beta thalassemia.

Condition or disease Intervention/treatment Phase
Beta Thalassemia Major Dietary Supplement: Spirulina Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: the Potential Immunomodulatory Effects of Spirulina on Thalassemic Children
Study Start Date : October 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thalassemia

Arms and Interventions
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Arm Intervention/treatment
Experimental: patients
thirty children with beta thalassemia major will receive oral spirulina (tablets=500 mg) for 3 months with a dose of 250 mg/kg/day (maximum dose 4 gm)
 Dietary Supplement: Spirulina
No Intervention: controls
thirty healthy children of matched age and sex


Outcome Measures
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Primary Outcome Measures :
  1. cluster of differentiation (CD4/CD25) ratio [ Time Frame: 3 months ]
  2. cluster of differentiation (CD33/CD11b/Lin) ratio [ Time Frame: 3 months ]
  3. serum immunoglobulins levels [ Time Frame: 3 months ]
  4. serum levels of interferon gamma [ Time Frame: 3 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • children with thalassemia major

Exclusion Criteria:

  • children with other chronic hemolytic anemias
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02674607


Locations
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Egypt
Faculty of Medicine- Tanta University
Tanta, Gharbia, Egypt, 0000
Sponsors and Collaborators
Tanta University
Investigators
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Principal Investigator: Mohamed R El-Shanshory, MD professor of pediatrics- head of hematooncology unit of pediatric department- Tanta University
More Information
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Responsible Party: Professor Mohamed Elshanshory, head of pediatric hematology and oncology unit, Tanta University
ClinicalTrials.gov Identifier: NCT02674607    
Other Study ID Numbers: 2132/10/13
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn