NCT02671695

Brief Summary

the aim of this study is to evaluate the effect of Spirulina compared to Amlodipine on cardiac iron overload and cardiac functions in multi-transfused children with beta thalassemia major

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

July 12, 2018

Status Verified

October 1, 2017

Enrollment Period

3 years

First QC Date

January 30, 2016

Last Update Submit

July 11, 2018

Conditions

Beta Thalassemia Major

Outcome Measures

Primary Outcomes (1)

  • cardiac iron concentration by magnetic resonance imaging

    3 months

Secondary Outcomes (2)

  • cardiac troponin 1

    3 months

  • N-terminal pro-brain natriuretic peptide

    3 months

Study Arms (2)

Group 1

EXPERIMENTAL

chelation therapy plus Spirulina capsules (500 mg) in a dose of 250 mg/kg/day orally for 3 months

Drug: Spirulina

Group 2

EXPERIMENTAL

chelation therapy plus Amlodipine in a dose of 5 mg/day orally for 3 months

Drug: Amlodipine

Interventions

SpirulinaDRUG

Spirulina capsules (500 mg) in a dose of 250 mg/kg/day orally for 3 months

Group 1
AmlodipineDRUG

Amlodipine in a dose of 5 mg/day orally for 3 months

Group 2

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patients on regular blood transfusions.
  • iron overload with no perspective of changing the chelation therapy in the following three months

You may not qualify if:

  • formal contraindication to magnetic resonance examinations
  • implantable cardiac device
  • advanced cardiomyopathy or conduction block
  • other types of 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

Related Publications (1)

  • Padhani ZA, Gangwani MK, Sadaf A, Hasan B, Colan S, Alvi N, Das JK. Calcium channel blockers for preventing cardiomyopathy due to iron overload in people with transfusion-dependent beta thalassaemia. Cochrane Database Syst Rev. 2023 Nov 17;11(11):CD011626. doi: 10.1002/14651858.CD011626.pub3.

    PMID: 37975597DERIVED

MeSH Terms

Conditions

beta-Thalassemia

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Sahar M El-Haggar, MD

    assisstant professor of clinical pharmacy- Faculty of Pharmacy- Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 30, 2016

First Posted

February 2, 2016

Study Start

April 1, 2015

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

July 12, 2018

Record last verified: 2017-10

Locations

EG(1)