Evaluation of the effect of amlodipine on oxidative stress markers and serum ferritin level in β-thalassemia patients undergoing iron chelation therapy: A randomized double-blind Cross-Over study
Evaluation of the effect of amlodipine on oxidative stress markers and serum ferritin level in β-thalassemia patients undergoing iron chelation therapy
Design
A randomized, double blind cross over clinical trial
Settings and conduct
This randomizes double blind cross over clinical trial will be conducted in Bouali Sina Educational Hospital in Sari.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
1. beta-thalassemia patients with moderate to severe heart iron overload (MRI T2 less than 15 milliseconds)
2. Age over 18 years
3. Informed written consent
Exclusion criteria:
1. Use of other calcium channel blocker (verapamil-diltiazem-carvedilol)
2. Continuous hypotension due to heart failure
3. Aortic valve stenosis
4. Sinoatrial node disease
5. Heart failure
Intervention groups
Beta-thalassemia patients with moderate to severe iron overload will be assigned into two groups including first amlodipine then placebo or first placebo then amlodipine.
Main outcome variables
Primary outcomes are oxidative stress markers (malondialdehyde, protein carbonyl and total antioxidant) and secondary outcome is ferritin level.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090613002027N16
Registration date:2019-09-17, 1398/06/26
Registration timing:registered_while_recruiting
Last update:2019-09-17, 1398/06/26
Update count:0
Registration date
2019-09-17, 1398/06/26
Registrant information
Name
Ebrahim Salehifar
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1311 6546
Email address
esalehifar@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-09, 1397/10/19
Expected recruitment end date
2019-12-10, 1398/09/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of amlodipine on oxidative stress markers and serum ferritin level in β-thalassemia patients undergoing iron chelation therapy: A randomized double-blind Cross-Over study
Public title
effect of amlodipine on oxidative stress markers and serum ferritin level in β-thalassemia patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Beta-thalassemia patients with moderate to severe heart sediment (based on MRI T2 less than 15 milliseconds)
Age over 18 years
Written informed consent
Exclusion criteria:
Other medicines for calcium blocker (verapamil-diltiazem-cartidilol)
Continuous hypotension due to heart failure
Aortic valve stenosis
Sinoatrial node diseas
Heart failure
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified randomization will be performed for patients based on MRI before enrollment in the study [MRI T2 of 10 to 15 milliseconds (moderate iron deposition in the heart) and MRI T2 of less than 10 milliseconds (severe iron deposition in the heart). ٌWhether the patient receives first Amlodipine then Placebo or first Placebo then Amlodipine will be determined by block randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
A separate 5-digit code obtained from the computer will be assigned to each patient.The intervention, including the drug or placebo, will be placed in identical containers, and the senior researcher will insert the code on the containers. The researcher and patient will not be aware of the type of intervention received.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Scienses, kilometer 18 of Farah Abad road, Sari, Iran
City
sari
Province
Mazandaran
Postal code
4816633131
Approval date
2019-01-06, 1397/10/16
Ethics committee reference number
IR.MAZUMS.REC.1398.281
Health conditions studied
1
Description of health condition studied
β-thalassemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
Oxidative stress indices (malondialdehyde, carbonyl protein and total antioxidant)
Timepoint
Baseline, month 6 and month 12
Method of measurement
Laboratory analysis
Secondary outcomes
1
Description
Ferritin
Timepoint
Baseline, month 6 and month 12
Method of measurement
Laboratory analysis
Intervention groups
1
Description
Intervention group: amlodipine tablets 5 mg daily for 6 months
Category
Treatment - Drugs
2
Description
Control group: Amlodipine placebo daily for 6 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Thalassemia Research Center
Full name of responsible person
Ebrahim Salehifar
Street address
Bu-Ali Sina Hospital, Blvd.Pasdaran, Sari, Iran
City
sari
Province
Mazandaran
Postal code
4816633131
Phone
Email
esalehifar@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Majid Saeedi
Street address
Research Deputy, Mazandaran university of medical Sciences, Moallem Square, Sari, Iran
City
sari
Province
Mazandaran
Postal code
861-48175
Phone
+98 11 3354 3241
Email
msaeedi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Salehifar
Position
Professor of Clinical Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy of Mazandaran University of Medical Sciences, Payambar azam University Complex, Farah Abad road, Sari, Iran
City
sari
Province
Mazandaran
Postal code
861-48175
Phone
+98 11 3354 3241
Email
salehifare@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Salehifar
Position
Professor of Clinical Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar squar
City
sari
Province
Mazandaran
Postal code
861-48175
Phone
+98 11 3354 3241
Email
salehifare@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ebrahim Salehifar
Position
Professor of Clinical Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy of Mazandaran University of Medical Sciences, Payambar azam University Complex, Farah Abad road, Khazar Square
City
sari
Province
Mazandaran
Postal code
861-48175
Phone
+98 11 3354 3241
Email
salehifare@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to confidentiality of patients data
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available