the Potential Immunomodulatory Effects of Spirulina on Thalassemic Children

October 24, 2017 updated by: Professor Mohamed Elshanshory, Tanta University
The aim of this study is to evaluate the possible immunologic effects of spirulina in children with beta thalassemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

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

4 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • children with thalassemia major

Exclusion Criteria:

  • children with other chronic 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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: controls
thirty healthy children of matched age and sex
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cluster of differentiation (CD4/CD25) ratio
Time Frame: 3 months
3 months
cluster of differentiation (CD33/CD11b/Lin) ratio
Time Frame: 3 months
3 months
serum immunoglobulins levels
Time Frame: 3 months
3 months
serum levels of interferon gamma
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: Mohamed R El-Shanshory, MD, professor of pediatrics- head of hematooncology unit of pediatric department- 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

October 1, 2015

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

February 1, 2016

First Submitted That Met QC Criteria

February 3, 2016

First Posted (Estimate)

February 4, 2016

Study Record Updates

Last Update Posted (Actual)

October 25, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2132/10/13

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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