Back to resultsthe Potential Immunomodulatory Effects of Spirulina on Thalassemic Children
Primary Purpose
Beta Thalassemia Major
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Spirulina
Sponsored by
About this trial
This is an interventional prevention trial for Beta Thalassemia Major
Eligibility Criteria
Inclusion Criteria:
- children with thalassemia major
Exclusion Criteria:
- children with other chronic hemolytic anemias
Sites / Locations
- Faculty of Medicine- Tanta University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
patients
controls
Arm Description
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)
thirty healthy children of matched age and sex
Outcomes
Primary Outcome Measures
cluster of differentiation (CD4/CD25) ratio
cluster of differentiation (CD33/CD11b/Lin) ratio
serum immunoglobulins levels
serum levels of interferon gamma
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02674607
Brief Title
the Potential Immunomodulatory Effects of Spirulina on Thalassemic Children
Official Title
the Potential Immunomodulatory Effects of Spirulina on Thalassemic Children
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to evaluate the possible immunologic effects of spirulina in children with beta thalassemia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Beta Thalassemia Major
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients
Arm Type
Experimental
Arm Description
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)
Arm Title
controls
Arm Type
No Intervention
Arm Description
thirty healthy children of matched age and sex
Intervention Type
Dietary Supplement
Intervention Name(s)
Spirulina
Primary Outcome Measure Information:
Title
cluster of differentiation (CD4/CD25) ratio
Time Frame
3 months
Title
cluster of differentiation (CD33/CD11b/Lin) ratio
Time Frame
3 months
Title
serum immunoglobulins levels
Time Frame
3 months
Title
serum levels of interferon gamma
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
children with thalassemia major
Exclusion Criteria:
children with other chronic hemolytic anemias
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed R El-Shanshory, MD
Organizational Affiliation
professor of pediatrics- head of hematooncology unit of pediatric department- Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine- Tanta University
City
Tanta
State/Province
Gharbia
ZIP/Postal Code
0000
Country
Egypt
12. IPD Sharing Statement
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the Potential Immunomodulatory Effects of Spirulina on Thalassemic Children
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