The aim of this study was to evaluate the role of folic acid in the treatment of patients with thalassemia major. In this study 40 patients over two years for at least 6 months, blood recipients who received folic acid supplements are examined. A blood sample at baseline and one month after cessation of folic acid a sample taken from the patient and folic acid and homocysteine levels in the blood can be measured and compared. This is a before and after study. It means that the control group will be the same with the case group.Over 2 years were enrolled and pregnant and lactating women are excluded. The study intervention is discontinued folic acid supplements and folic acid and homocysteine levels as the primary outcome variable.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011425989N2
Registration date:2016-03-14, 1394/12/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-14, 1394/12/24
Registrant information
Name
Bahram Darbandi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 9061
Email address
darbandi45@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Guilan University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Amount of Folic Acid and Homocysteine in Patients With Major Beta Thalassemia Recipient of Blood over 2 Years
Public title
The Impact of Folic Acid in The Treatment of Major - Thalassemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Patients over Two Years of Age with Thalassemia Major Blood Recipient who Received Folic Acid Supplements for at Least 6 Months
Exclusion Criteria: Under two Years; Pregnant Women; Lactating Women
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
This is a before and after study. It means that the control group will be the same with the case group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
10th KM of Tehran Road
City
Rasht
Postal code
Approval date
2015-11-20, 1394/08/29
Ethics committee reference number
ir.gums.rec.1394.35
Health conditions studied
1
Description of health condition studied
Beta Thalassemia
ICD-10 code
D56.1
ICD-10 code description
Thalassemia(anemia) (disease)- major D56.1
Primary outcomes
1
Description
Serum folic acid levels
Timepoint
Supplements before and one month after stopping it
Method of measurement
In terms of micrograms per liter and by chemiluminescence
2
Description
Serum homocysteine level
Timepoint
Supplements before and one month after stopping it
Method of measurement
In terms of micromoles per liter and by chemiluminescence
Secondary outcomes
empty
Intervention groups
1
Description
In this study one milligram of folic acid supplements daily for patients already taking a number were cut off for a month. In this review we have one study group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasht 17th Shahrivar Hospital
Full name of responsible person
Dr.Hajar Hemmati
Street address
Rasht-17th Shahrivar Hospital
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Guilan University ofMedical Sciences
Full name of responsible person
Dr.Rasul Tabari
Street address
Rasht- Gas ُSquare
City
Rasht
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Guilan University ofMedical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Medical Sciences of Guilan University
Full name of responsible person
Dr.Hajar.Hemmati
Position
Resident Assistance of Pediatrics
Other areas of specialty/work
Street address
17th shahrivar hospital
City
Rasht
Postal code
Phone
+98 333369019
Fax
Email
yasna.hemmati@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical Sciences of Guilan University
Full name of responsible person
Dr.Bahram Darbandi
Position
Specialty pediatric cancer and blood/Assistant Professor
Other areas of specialty/work
Street address
17th Shahrivar hospital
City
Rasht
Postal code
Phone
+98 13 3336 9044
Fax
Email
darbandi45@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medical Sciences of Guilan University
Full name of responsible person
Dr.Hajar.Hemmati
Position
Assistant Professor of Pediatrics
Other areas of specialty/work
Street address
17th Shahrivar
City
Rasht
Postal code
Phone
+98 13 3336 9044
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)