Iron overload especially in the heart is one of the most important causes of death among patients with major thalassemia. Iron uptake by using iron chelators is one of the main therapeutic methods in the patients. This study was done to compare the therapeutic effects of defroxamine and deferiprone combination therapy and defroxamine alone in patients of Mazandaran Iran. In this clinical trial, major thalassemia patients with serum ferritin > 3000 ng/ml were divided in two groups and matched based on age, sex, serum ferritin level and systolic cardiac function (LVEF). First group received desferrixamine (DFO) alone 50-60 mg/kg/dAY, and second received combination therapy of deferiprone 50-75mg/kg/DAY and DFO 30-35 mg/kg/DAY. Patients were visited every 6 months for physical exam and serum ferritin, mean of Hb, AST, ALT and LVEF recorded from 6 months before the study and then measured and recorded in each visit. Data were analyzed using repeated measurements, t-test and χ² test .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810203032N1
Registration date:2010-11-08, 1389/08/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-11-08, 1389/08/17
Registrant information
Name
Hossein Karami
Name of organization / entity
Mazandaran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1223 4506
Email address
hokarami@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology of Mazandran University of Medical Sciences
Expected recruitment start date
2005-12-22, 1384/10/01
Expected recruitment end date
2007-12-22, 1386/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparsion of combination therapy with Deferiprone plus desferrioxamine versus desferrioxamine alone in patients with major beta thalassemia
Public title
Treatment effect of deferiprone and desferrioxamine in beta thalassemia major
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Confirmed major thalassemia by Hemoglubin elctrophoresis
2- Age ranged 5-30 years
3- Serum ferritin level more than 3000 ng/ml
4- Written consent from patients or parents
Exclusion criteria:
1- Disagreement of patients or parents for begining of treatment
2- Deferiprone sensitivity
3- Desferrioxamine sensitivity
3-
Age
From 5 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Mazandaran University of Medical sciences, Sari/ Iran
Street address
Mazandaran University of Medical sciences, Sari/ Iran
City
Sari
Postal code
Approval date
empty
Ethics committee reference number
8412
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
Serum ferritin
Timepoint
6 months
Method of measurement
Immuno Radiaometric Assay
2
Description
Left ventricle ejection fraction
Timepoint
6 months
Method of measurement
Echocardiography
Secondary outcomes
1
Description
Hemoglobin
Timepoint
6 months
Method of measurement
Electronic counter
2
Description
AST
Timepoint
6 months
Method of measurement
PARS AZMUN Kit
3
Description
ALT
Timepoint
6 months
Method of measurement
PARS AZMUN Kit
Intervention groups
1
Description
Desferrixamine alone 50-60 mg/kg/day
Category
Treatment - Drugs
2
Description
Combination therapy of deferiprone 50-75 mg/kg/day and desferrioxamine 30-35 mg/kg/day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mazandaran thalassemia research center
Full name of responsible person
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazndaran University of Medical Science
Full name of responsible person
Hossein Karami
Street address
Mazndaran University of Medical Science
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazndaran University of Medical Science
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
Mazndaran University of Medical Science
Full name of responsible person
Hossein Karami
Position
Assistant Professor of Pediatric Hematology and Oncology
Other areas of specialty/work
Street address
Mazandaran thalassemia research center, Booali Sina Hospital, Sari
City
Sari
Postal code
4815733971
Phone
+98 15 1214 4295
Fax
Email
hokarami@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazndaran University of Medical Sciences
Full name of responsible person
Hossein Karami
Position
Assistant Professor of Pediatric Hematology and Oncology
Other areas of specialty/work
Street address
Mazandaran thalassemia research center, Booali Sina Hospital, Sari
City
Sari
Postal code
4815733971
Phone
+98 15 1214 4295
Fax
Email
hokarami@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)