Beta thalassemia is a hereditary disorder of hemoglobin that results in impaired synthesis of beta-globin chains, leading to hemolytic anemia. Regular blood transfusion is essential for long-term survival of patients, but iron overload occurs gradualy in various tissues. Heart disease is most common cause of death in these patients due to iron deposition in the heart muscle. The MRI T2 * as a non-invasive method for quantitative measurement of cardiac iron can be used to follow response to iron chelator therapy. The aim of this study was to compare the effect of Deferoxamine , Deferasirox, and combination therapy of Deferoxamine and deferiprone on cardiac iron burden as measured by MRI T2 * in thalassemia major patients at Ali Asghar Children's Hospital and Zafar clinic of adult thalassemia .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012091710862N1
Registration date:2013-06-20, 1392/03/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-06-20, 1392/03/30
Registrant information
Name
Ghasem Mirialiabad
Name of organization / entity
Tehran University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 21 2304 6411
Email address
mirialiabad@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Iron Chelation Effects of Deferoxamine, Deferasirox, and Combination of Deferoxamine and Deferiprone in Thalassemia Maior
Public title
Iron Chelators Effects in Thalassemia Maior
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: transfusion dependent thalassemia with age over 10 years;cardiac iron load on MRI T2 *
Exclusion criteria : severe hepatic disorder; renal disease; history of neutropenia; history of adverse reactions to any of chelators in the past; failure to perform MRI T2 * due to causes such as pacemakers; pregnancy; fear of closed environment
Age
From 10 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Tehran University of Medical Sciences
Street address
Central Organization of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd, Tehran, Iran
City
Tehran
Postal code
Approval date
2012-06-20, 1391/03/31
Ethics committee reference number
91/د/130/385
Health conditions studied
1
Description of health condition studied
Major thalassemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassaemia
Primary outcomes
1
Description
srum ferritin, ng/ml
Timepoint
0 and 12 month later
Method of measurement
RIA
Secondary outcomes
1
Description
Cardiac Iron Load
Timepoint
0 and 12 month later
Method of measurement
Cardiac MRI T2*
Intervention groups
1
Description
The first group was treated with subcutaneous infusion of 30-50 mg/kg/day deferoxamine during 8-12 hours for at least 5-6 nights a week using a pumpfor at least one year .
Category
Treatment - Drugs
2
Description
The second group received 20-40 mg/kg/day deferasirox as a single oral dose before the first meafor at least one year l.
Category
Treatment - Drugs
3
Description
The third group was treated with subcutaneous infusion of 30-50 mg/kg/day deferoxamine during 8-12 hours for at least 5-6 nights a week using a pump and 75-100 mg/kg/day oral deferiprone in three divided doses for at least one year .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Asghar Children’s Hospital and adult thalassemia clinic of Zafar
Full name of responsible person
Ghasem Mirialiabad
Street address
No. 193 , Dastgerdi St, Shariati St, Ali Asghar Children’s Hospital, Tehran University of Medical Sciences and Health Services, Tehran, Iran.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences Vice chancellor for research
Full name of responsible person
Dr. Akbar Fotouhi (Research Deputy of Tehran University of Medical Sciences)
Street address
Central Organization of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences Vice chancellor for research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahla Ansari
Position
Associate professor of pediatric
Other areas of specialty/work
Street address
No. 193 , Dastgerdi St, Shariati St, Ali Asghar Children’s Hospital, Tehran University of Medical Sciences and Health Services, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21230461411
Fax
Email
shahladamavandi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahla Ansari
Position
associate professor of pediatric
Other areas of specialty/work
Street address
No. 193 , Dastgerdi St, Shariati St, Ali Asghar Children’s Hospital, Tehran University of Medical Sciences and Health Services, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 2304 6411
Fax
Email
shahladamavandi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ghasem Miri-Aliabad
Position
Fellowship of pediatric oncology
Other areas of specialty/work
Street address
No. 193 , Dastgerdi St, Shariati St, Ali Asghar Children’s Hospital, Tehran University of Medical Sciences and Health Services, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 2304 6411
Fax
Email
gh_miri@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)