Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE February 1, 2016
First Posted Date  ICMJE February 4, 2016
Last Update Posted Date October 25, 2017
Study Start Date  ICMJE October 2015
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2016)
  • cluster of differentiation (CD4/CD25) ratio [ Time Frame: 3 months ]
  • cluster of differentiation (CD33/CD11b/Lin) ratio [ Time Frame: 3 months ]
  • serum immunoglobulins levels [ Time Frame: 3 months ]
  • serum levels of interferon gamma [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE the Potential Immunomodulatory Effects of Spirulina on Thalassemic Children
Official Title  ICMJE the Potential Immunomodulatory Effects of Spirulina on Thalassemic Children
Brief Summary The aim of this study is to evaluate the possible immunologic effects of spirulina in children with beta thalassemia.
Detailed Description Not Provided
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: Prevention
Condition  ICMJE Beta Thalassemia Major
Intervention  ICMJE Dietary Supplement: Spirulina
Study Arms  ICMJE
  • 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)
    Intervention: Dietary Supplement: Spirulina
  • No Intervention: controls
    thirty healthy children of matched age and sex
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: February 3, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • children with thalassemia major

Exclusion Criteria:

  • children with other chronic hemolytic anemias
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT02674607
Other Study ID Numbers  ICMJE 2132/10/13
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: Mohamed R El-Shanshory, MD professor of pediatrics- head of hematooncology unit of pediatric department- 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