Aim of this study is evaluation of Pantaprazol effect on cardiac &hepatic iron overload assessd by T2* MRI in patient with major and intermediate Thalassemia in Amirkabir hospital of Arak.This study clinical trials. Patients with more than 7 years divide in 2 groups. We measure Feritin and T2* MRI in cardiac and hepatic in two groups in first study. We prescribe 1 milligram in kilogram of Pantaprazol daily before breakfast(maximum dose 40 milligram) for 6 months in intervention group.We don't prescribe drug in control group. We measure Feritin and T2* MRI in cardiac and hepatic in two groups after 6 months.
Inclusion criteria: Patients with major and intermediate Thalassemia; age more than 7 years
Exclusion criteria: Drug intolerance; unwilling to participate in the study; heart failure; hepatitis; HIV
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017042220258N40
Registration date:2017-09-03, 1396/06/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-03, 1396/06/12
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research,Arak University of Medical Sciences
Expected recruitment start date
2017-04-08, 1396/01/19
Expected recruitment end date
2018-05-09, 1397/02/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Pantaprazol on cardiac and hepatic iron overload assessd by T2* MRI in patient with major and intermediate Thalassemia
Public title
Evaluation of Pantaprazol on cardiac and hepatic iron overload in patient with major and intermediate Thalassemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with major and intermediate Thalassemia; age more than 7 years
Exclusion criteria: Drug intolerance; unwilling to participate in the study; heart failure; hepatitis; HIV
Age
From 7 years old to 139 years old
Gender
Both
Phase
2-3
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
Randomize with random numbers
blindness: researcher than complete data don't aware grouping and analyzer don't aware grouping
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Dr Mohammad Rafie, Vice Chancellor Research, Payambar Azam complex, Basij square, Sardasht, Arak
City
Arak
Postal code
38149578558
Approval date
2017-03-06, 1395/12/16
Ethics committee reference number
IR.ARAKMU.REC.1395.434
Health conditions studied
1
Description of health condition studied
major and intermediate Thalasemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassaemia
Primary outcomes
1
Description
Feritin in serum
Timepoint
before and 6 months after 6 treatment
Method of measurement
Blood test
2
Description
Heart and liver iron load
Timepoint
before and 6 months after 6 treatment
Method of measurement
MRI * 2T
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We prescribe 1 milligram in kilogram of Pantaprazol daily before breakfast (maximum dose 40 milligram) for 6 months in intervention group.
Category
Treatment - Drugs
2
Description
Intervention group: We don't prescribe drug in control group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Dr Aziz Eghbali
Street address
Amirkabir hospital, Parastar square, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor forResearch, Arak University of Medical Sciences