Understanding the importance of treating vitamin D deficiency in patients with thalassemia major The aim of this study is to investigate the role of vitamin D treatment in increasing left ventricular ejection fraction in hemosidosis with the aim of improving the quality of life and survival of thalassemia major patients.
Design
Eligible children with Beta thalasemiawill include in this study after obtaining consent. A code was allocated to each one of them.
Settings and conduct
Children with Beta thalasemia, that referred to Neurology Clinic of Tabriz Children Hospital will purposefully be chosen and included in the study after the diagnisis and confirmation of the TSC disease by a medical specialist and getting informed consent. The patients with underlying diseases and or with drug prohibition will be excluded from the study.
Participants/Inclusion and exclusion criteria
Children with Beta thalasemia, that referred to Neurology Clinic of Tabriz Children Hospital will purposefully be chosen and included in the study after the diagnisis and confirmation of the TSC disease by a medical specialist and getting informed consent. The patients with underlying diseases and or with drug prohibition will be excluded from the study.
Intervention groups
Based on the references, vitamin D will be administered The patients will be evaluated for any probable side effect of the drug during the administration period.
Main outcome variables
Understanding the importance of treating vitamin D deficiency in patients with thalassemia major The aim of this study is to investigate the role of vitamin D treatment in increasing left ventricular ejection fraction in hemosidosis with the aim of improving the quality of life and survival of thalassemia major patients.
General information
Reason for update
Acronym
TVDTM
IRCT registration information
IRCT registration number:IRCT20150618022805N2
Registration date:2018-04-28, 1397/02/08
Registration timing:retrospective
Last update:2018-04-28, 1397/02/08
Update count:0
Registration date
2018-04-28, 1397/02/08
Registrant information
Name
Amir Ataollah Hiradfar
Name of organization / entity
Pediatric Health Research Center, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3526 2251
Email address
hiradfara@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
2016-03-20, 1395/01/01
Actual recruitment end date
2017-03-21, 1396/01/01
Trial completion date
empty
Scientific title
The role of vitamin D on the left ventricle ejection fraction in thalassemia major patients with cardiac hemosiderosis in Tabriz children’s hospital
Public title
The role of vitamin D on the left ventricle ejection fraction in thalassemia major patients with cardiac hemosiderosis in Tabriz children’s hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Reduction of left ventricular ejection fraction by less than 55% based on echocardiography of the last three months
3. Treated with heart failure diagnosis by heart service
4. Level 25-Hydroxyvitamin D less than 30 ng / dl
5. Normal PTH serum levels
6. Serum magnesium levels are normal
Exclusion criteria:
1. Exacerbation of heart failure
2. Occurrence of arrhythmias
3. Serum 25-Hydroxyvitamin D levels greater than 80 ng / dl
4. Severe constipation
5. Muscle weakness
Age
From 6 months old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
125
Actual sample size reached:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Patients referred to the study are randomly divided into control and control groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Regional Ethics Committee, Office of the Vice Chancellor for Research, Tabriz University of Medica
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz, PO Box: 5165665931, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2018-03-18, 1396/12/27
Ethics committee reference number
IR.TBZMED.REC.1396.1287
Health conditions studied
1
Description of health condition studied
Major thalassemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
Vitamin D
Timepoint
Eevery 4 weeks
Method of measurement
Blood sample-questionnaire
2
Description
Heart hemosiderosis
Timepoint
Every 4 weeks
Method of measurement
Echocardiography-questionnaire
Secondary outcomes
1
Description
Constipation
Timepoint
During the administration period
Method of measurement
En Clinical Examination, Questionnaire
Intervention groups
1
Description
Vitamin D will be administered intramuscularly at a dosage of 50,000 units for the case group for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Children Hospital
Full name of responsible person
Dr amir ataloah hiradfar
Street address
Tabriz Children Hospital, Sheshgelan Street, Tabriz, Iran.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2250
Fax
+98 41 3526 2265
Email
hiradfar@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Barzegar
Street address
Pediatric Health Research Center, Tabriz Children Hospital, Sheshgelan Street, Tabriz, Iran.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2265
Fax
+98 41 3526 2265
Email
phrc_mb@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. amir ataloah hiradfar
Position
Pediatric Oncologist, Professor, Faculty Member
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Pediatric Health Research Center, Children Hospital, Sheshgelan street, Tabriz, Iran.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2265
Fax
+98 41 3526 2265
Email
phrc_mb@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Amirataloah Hiradfar
Position
Pediatric Oncolologist
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Pediatric Health Research Center, Tabriz Children Hospital, Sheshgelan Street, Tabriz, Iran.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+41 35262265
Fax
+98 41 3526 2265
Email
phrc_mb@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Aziz Hasanzadeh
Position
Pediatric resident
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Tabriz Children Hospital, Sheshgelan Street, Tabriz, Iran.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2265
Fax
+98 41 3526 2265
Email
hiradfarataolah@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
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
Understanding the importance of treating vitamin D deficiency in patients with thalassemia major The aim of this study is to investigate the role of vitamin D treatment in increasing left ventricular ejection fraction in hemosidosis with the aim of improving the quality of life and survival of thalassemia major patients.
When the data will become available and for how long
n/a
To whom data/document is available
n/a
Under which criteria data/document could be used
n/a
From where data/document is obtainable
n/a
What processes are involved for a request to access data/document