NCT02674607

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

2 years

First QC Date

February 1, 2016

Last Update Submit

October 24, 2017

Conditions

Beta Thalassemia Major

Outcome Measures

Primary Outcomes (4)

  • cluster of differentiation (CD4/CD25) ratio

    3 months

  • cluster of differentiation (CD33/CD11b/Lin) ratio

    3 months

  • serum immunoglobulins levels

    3 months

  • serum levels of interferon gamma

    3 months

Study Arms (2)

patients

EXPERIMENTAL

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

controls

NO INTERVENTION

thirty healthy children of matched age and sex

Interventions

SpirulinaDIETARY_SUPPLEMENT
patients

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • children with thalassemia major

You may not qualify if:

  • children with other chronic hemolytic anemias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine- Tanta University

Tanta, Gharbia Governorate, 0000, Egypt

Location

MeSH Terms

Conditions

beta-Thalassemia

Condition Hierarchy (Ancestors)

ThalassemiaAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Mohamed R El-Shanshory, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of pediatric hematology and oncology unit

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 4, 2016

Study Start

October 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

October 25, 2017

Record last verified: 2017-10

Locations

EG(1)