In this study, patients with beta-thalassemia major dependent on blood transfusion referred to the thalassemia center of Bu-Ali Sina Hospital in Sari, who use Nanojade compound once a day with a dose of 14 to 20 mg per day for iron removal, but their serum ferritin is higher than 2500, or because of gastrointestinal complications, they are unable to take Nanojade with the mentioned dose and have ferritin higher than 2500 ng/dL, are selected and the drug is prescribed for them with the same dose but twice a day for one year. The control group will continue to take the drug once a day.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age over 2 years
Beta thalassemia major patients dependent on blood transfusion
under single-drug treatment with the iron chelator drug, Nanojade, for at least 6 months and ferritin above 2500 ng/dL or a patient with gastrointestinal side effects of drug use and ferritin above 2500 ng/dL
Exclusion criteria:
Unwillingness to participate in the study
Failure to take medication correctly
Complications leading to drug discontinuation
Intervention groups
Intervention group Nanojade product of Nanohayat company twice daily 14 to 20 mg per day.
The control group consists of taking Nanojade product of Nanohayat company once daily, 14 to 20 mg per day.
Main outcome variables
Liver Iron Concentration (LIC), Serum Ferritin, Heart and Liver iron load using T2-star
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100110003032N3
Registration date:2023-02-28, 1401/12/09
Registration timing:prospective
Last update:2023-02-28, 1401/12/09
Update count:0
Registration date
2023-02-28, 1401/12/09
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
Expected recruitment start date
2023-03-06, 1401/12/15
Expected recruitment end date
2024-03-05, 1402/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy and safety of Nanojade twice daily versus Nanojade once daily in transfusion-dependent thalassemia patients
Public title
Investigating the efficacy and safety of twice daily Nanojade in transfusion-dependent thalassemia patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 2 years and older
Blood transfusion-dependent major beta-thalassemia
Under treatment with single iron chelator for at least 6 months and ferritin above 2500 ng/dL or patient with gastrointestinal side effects and ferritin above 2500 nd/dL
Exclusion criteria:
Unwillingness to participate in the study
Age
From 2 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: simple randomization
Randomization Unit: Individual
Randomization tool: table of random numbers
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
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Pasdaran Blvd , Boali Sina Hospital
City
Sari
Province
Mazandaran
Postal code
4717844718
Approval date
2023-01-04, 1401/10/14
Ethics committee reference number
IR.MAZUMS.REC.1401.463
Health conditions studied
1
Description of health condition studied
Major beta-thalassemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
Liver Iron Concentration (LIC) mg Fe/g
Timepoint
Before starting the intervention and 6-12 months after the intervention
Method of measurement
Liver biopsy
Secondary outcomes
1
Description
Serum Urea concentration
Timepoint
Monthly after start of intervention until 12 month
Method of measurement
Serum biochemistry
2
Description
Drug side effects
Timepoint
At the start of intervention until end of intervention
Method of measurement
Patient report
3
Description
Serum Ferritin
Timepoint
At the start of intervention until end of intervention
Method of measurement
Serum biochemistry assay
4
Description
Serum Creatinine concentration (mg/dL)
Timepoint
Monthly after start of intervention until 12 month
Method of measurement
Serum biochemistry assay
5
Description
Serum Calcium concentration (mg/dL)
Timepoint
Monthly after start of intervention until 12 month
Method of measurement
Serum biochemistry assay
6
Description
Serum Phosphor concentration (mg/dL)
Timepoint
Monthly after start of intervention until 12 month
Monthly after start of intervention until 12 month
Method of measurement
Serum biochemistry assay
8
Description
Serum Aspartate Aminotransferase (mg/dL)
Timepoint
Monthly after start of intervention until 12 month
Method of measurement
Serum biochemistry assay
9
Description
Serum Alkaline Phosphates (mg/dL)
Timepoint
Monthly after start of intervention until 12 month
Method of measurement
Serum biochemistry assay
10
Description
Serum Bilirubin concentration (mg/dL)
Timepoint
Monthly after start of intervention until 12 month
Method of measurement
Serum biochemistry assay
Intervention groups
1
Description
Intervention group: 14 to 20 mg of Nanojade, product of Nanohayat company, twice daily for 12 months
Category
Treatment - Drugs
2
Description
Control group: 14 to 20 mg of Nanojade, product of Nanohayat company, once daily for 12 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu-Ali Sina Hospital
Full name of responsible person
Hossein Karami
Street address
Bu-Ali Sina Hospital, Pasdaran Blvd., Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3014
Email
hokarami@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Hossein Karami
Street address
Mazandaran University of Medical Sciences, Valiasr Highway
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3304 4000
Email
pajhoheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Hossein Karami
Position
Assistant Professor of Pediatric Hematology and Oncology
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Mazandaran thalassemia research center, Bu-Ali Sina Hospital, Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
00981512144295
Fax
Email
hokarami@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hossein Karami
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Bu-Ali Sina Hospital, Pasdaran Blvd.
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3014
Email
hokarami@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hossein Karami
Position
Assistant Professor of Pediatric Hematology and Oncology
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Mazandaran thalassemia research center, Booali Sina Hospital, Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
00981512144295
Fax
Email
hokarami@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Main outcome data can be obtained after sending the request to the principal investigator. Patients personal data will be anonymous.
When the data will become available and for how long
6 months after publication
To whom data/document is available
Investigators from university and scientific organizations
Under which criteria data/document could be used
Data could be used for verification of the study and secondary analysis
From where data/document is obtainable
It will be possible to receive data by sending an e-mail request to the main researcher, Dr. Hossein Karami, Thalassemia Center of Bu-Ali Sina Hospital, Sari.
Email: hokarami@mazums.ac.ir
What processes are involved for a request to access data/document
The request will be reviewed by the main researcher after receiving it, and the data will be accessible up to one month after sending the request, if approved.