Main Goal
The Role of Vitamin D Supplements is determined on the Rate of Pulmonary Hypertension in Patients with Thalassemia Major and Intermedia.
Design
A clinical trial with control group in phase 3, parallel groups design of 14 patient for each group. Simple randomization using random sequences of integers.
Settings and conduct
In this Clinical Trial, Patients with Beta Thalassemia Major and Intermedia referred to Amir-Kabir hospital in Arak, are randomly assigned to two groups. At the onset of the Study, All Patients undergo Echocardiography to measure Pulmonary Arterial Pressure and also measure Serum Vitamin D Levels. Then a group of Patients will be treated with Vitamin D, at a dose of 500,000 units per week for 20 weeks, and the Second group will not receive any Medication. Six months later, Serum Vitamin D Levels and Pulmonary Arterial Pressure will be measured again in all Patients.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
1. Parental Informed Consent
2. Patients with Thalassemia Major under Regular Transfusion and Regular Chelation.
3. Patients with Thalassemia Intermedia who do not have Regular Transfusion.
Exclusion Criteria
1. Parental Dissatisfaction for Participation in the Study
2. Congenital and Non-congenital Heart Disease
3. Endocrine Disease such as Diabetes, Hypoparathyroidism and Hypothyroidism
4. Oral Intolerance
Intervention groups
Individuals in the Intervention Group are treated with Oral Vitamin D, at a dose of 500,000 units per week, for 20 weeks.
Control Group's Individuals will not receive any Medication and Intervention.
Main outcome variables
Pulmonary Hypertension
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190206042644N1
Registration date:2019-03-11, 1397/12/20
Registration timing:retrospective
Last update:2019-03-11, 1397/12/20
Update count:0
Registration date
2019-03-11, 1397/12/20
Registrant information
Name
Fatemeh Fadayi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3420 4232
Email address
shaqayeqfadayi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-06-19, 1398/03/29
Actual recruitment start date
2018-10-23, 1397/08/01
Actual recruitment end date
2019-01-08, 1397/10/18
Trial completion date
empty
Scientific title
Evaluation of the Role of Vitamin D Supplements on Pulmonary Hypertension in Patients with Thalassemia Major and Intermedia
Public title
The Role of Vitamin D Supplements on Pulmonary Hypertension in Patients with Thalassemia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Parental Informed Consent
Patients with Thalassemia Major under Regular Transfusion and Regular Chelation.
Patients with Thalassemia Intermedia who do not have Regular Transfusion.
Exclusion criteria:
Parental Dissatisfaction for Participation in the Study
Congenital and Non-congenital Heart Disease
Endocrine Disease such as Diabetes, Hypoparathyroidism and Hypothyroidism
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, using the random sequence numbers obtained from https://www.random.org/.
In this way, each person is assigned a number from 1 to 28, then from the site, two random groups are obtained from numbers 1 to 28, the first group as the intervention group and the second group is considered as the control group.
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 Arak University of Medical Sciences
Street address
Ethics committee of Arak University of Medical, Arak University of Medical Science, Basij Sq.
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2018-09-23, 1397/07/01
Ethics committee reference number
IR.ARAKMU.REC.1397.148
Health conditions studied
1
Description of health condition studied
Pulmonary Hypertension
ICD-10 code
I27.0
ICD-10 code description
Primary pulmonary hypertension
2
Description of health condition studied
Thalassemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
Pulmonary Hypertension
Timepoint
Measurement of Pulmonary Arterial Pressure at the Beginning of the Study (After Entering the Study and Before the Onset of the Intervention) and Repeat Measurements 6 months after Entry into the Study.
Method of measurement
Echocardiography by Echocardiologist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Individuals in this Group are treated with Oral Vitamin D, at a dose of 500,000 units per week, for 20 weeks.
Category
Prevention
2
Description
Control group: People in this Group will not receive any Medication and Intervention.
Office of the Vice-chancellor for Research, Arak University of Medical Science, Basij Sq.
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Fax
+98 86 3417 3645
Email
research@arakmu.ac.ir
Web page address
https://arakmu.ac.ir/vcr/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Fadayi
Position
Medical Stundent
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Abolmasumi Deadend, A'lamolhoda Blvd
City
Arak
Province
Markazi
Postal code
3819717575
Phone
+98 26 3420 4232
Fax
Email
shaqayeqfadayi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Fadayi
Position
Medical Stundent
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Abolmasumi Deadend, A'lamolhoda Blvd
City
Arak
Province
Markazi
Postal code
3819717575
Phone
+98 26 3420 4232
Fax
Email
shaqayeqfadayi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fatemeh Fadayi
Position
Medical Stundent
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Abolmasumi Deadend, A'lamolhoda Blvd
City
Arak
Province
Markazi
Postal code
3819717575
Phone
+98 26 3420 4232
Fax
Email
shaqayeqfadayi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not 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
Data of Participants in this Study, which will be shared after being unidentified, include Age, Sex, Serum Levels of Vitamin D before and after intervention, and Pulmonary Arterial Pressure before and after intervention.
When the data will become available and for how long
The beginning of the Data Access Period for this Study will be One year after the Results are Published, and these Data are available for 2 years.
To whom data/document is available
This data will be accessible to researchers and students working in universities and research centers who intend to conduct supplementary studies or studies similar to this research.
Under which criteria data/document could be used
Use of data to carry out any kind of study and analysis is allowed by mentioning source.
From where data/document is obtainable
To access this data, contact one of the following ways, with "Fatemeh Fadayi" contributor:
1. Phone No.: 0098 935 0246
2. Email: Shaqayeqfadayi@gmail.com
What processes are involved for a request to access data/document
A ready-made file of shareable data will be provided, and applicants for data access, will receive the data as soon as possible after they have introduced their goal to access the data.