50 patients with major thalassemia who have never received any chelator therapy but been candidate for that, are selected. All the patients go through examinations by an ophthalmologist, and those having any lens opacity will be excluded. Then the patients will be divided into two 25 membered groups, and each group will receive one of the chelators randomly. All the patients will go through re-examinations after one year, with the results of the both groups compared. In the case of having less lens opacity in osferal group, the drug could be prescribed much more safely.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110087677N1
Registration date:2011-10-16, 1390/07/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-10-16, 1390/07/24
Registrant information
Name
Mohamadreza Golpayegani
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6331
Email address
golpayegani@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2010-12-22, 1389/10/01
Expected recruitment end date
2011-12-22, 1390/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative study of incidence of lens opacity between Osferal and Deferoxamine in major thalassemia
Public title
The comparison of eye side effects of Osferal and Deferoxamine in patients with major thalassemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children having major thalassemia , being candidate for chelator therapy because of iron overload
Exclusion criteria: diabetes mellitus and rheumatologic diseases, any lens disease or chelator therapy before the study
Age
From 1 year old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The research and technology vice of KUMS
Street address
building no:2, shaheed beheshti Blvd., KUMS
City
Kermanshah
Postal code
Approval date
2010-06-28, 1389/04/07
Ethics committee reference number
پ/7/711/1765
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
Lens opacity
Timepoint
After one year
Method of measurement
Ophthalmologic examinations
Secondary outcomes
1
Description
Age- Gender- Family history
Timepoint
One year
Method of measurement
Answer sheet
Intervention groups
1
Description
Intervention:In this group, 25 patients are put on a new irainian drug e; Osferal, and then it's side effect that is "lens opacity", will be compared with that of the control group.
Category
Treatment - Drugs
2
Description
Control:Based on the present policy, 25 patients who receive Deferoxamine and have a known percent of "lens opacity", are considered as the control group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Thalassemia centre
Full name of responsible person
Reza Akramipoor
Street address
Imam Reza hospital, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Building no:2, shahid Beheshti blvd., Kums
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Kermanshah University of Medical Sciences
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
Imam Reza hospital, KUMS
Full name of responsible person
Vahid Falahati
Position
Resident of pediatrics
Other areas of specialty/work
Street address
Imam Reza hospital, KUMS
City
Kermanshah
Postal code
Phone
+98 83 1427 6333
Fax
Email
vahidfalahati89@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imamreza hospital, KUMS
Full name of responsible person
Mohammadreza Golpayegani
Position
Pediatric oncologist
Other areas of specialty/work
Street address
Imamreza hospital, KUMS
City
Kermanshah
Postal code
Phone
+98 83 1427 6333
Fax
Email
golpayegani@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Vahid Falahati
Position
pediatric resident
Other areas of specialty/work
Street address
Imam Reza hospital Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1427 6333
Fax
Email
vahidfalahati89@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)