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the Potential Immunomodulatory Effects of Spirulina on Thalassemic Children

NCT ID: NCT02674607

Last Updated: 2017-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-10-31

Brief Summary

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The aim of this study is to evaluate the possible immunologic effects of spirulina in children with beta thalassemia.

Detailed Description

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Conditions

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Beta Thalassemia Major

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

Spirulina

Intervention Type DIETARY_SUPPLEMENT

controls

thirty healthy children of matched age and sex

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Spirulina

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* children with thalassemia major

Exclusion Criteria

* children with other chronic hemolytic anemias
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Professor Mohamed Elshanshory

head of pediatric hematology and oncology unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed R El-Shanshory, MD

Role: PRINCIPAL_INVESTIGATOR

professor of pediatrics- head of hematooncology unit of pediatric department- Tanta University

Locations

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Faculty of Medicine- Tanta University

Tanta, Gharbia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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2132/10/13

Identifier Type: -

Identifier Source: org_study_id