determine effect of vitamin D treatment on liver involvement severity in patients suffered from non alcoholic fatty liver
Design
Clinical trials without control group, not blinded and not randomised
Settings and conduct
This study will be conducted on patients with non-alcoholic fatty liver disease who are referred to the Center for Applied Scientific Research and after receiving their consent. The intervention group will receive 50000mg vitamin D for 4 months on an weekly basis. Patients will be screened for ultrasound examination of fatty liver gradients. Measurement of the level of liver enzymes will be taken part in the Danesh lab and performance of ultrasound in the Tabesh imaging center.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients who have been diagnosed with non-alcohol fatty liver with vitamin D deficiency
Exclusion criteria: alcohol consumption history; cancers; melitus diabetics; thyroid disease; chronic kidney disease
Intervention groups
the case group will receive 50000mg Vitamin D weekly whereas the control group will receive nothing.
Main outcome variables
Liver Enzymes (AST; ALT); ultrasound grade
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150802023468N6
Registration date:2019-10-28, 1398/08/06
Registration timing:retrospective
Last update:2019-10-28, 1398/08/06
Update count:0
Registration date
2019-10-28, 1398/08/06
Registrant information
Name
Nazli Rabienejad
Name of organization / entity
Hamadan university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1059
Email address
n.rabinezhad@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The relationship between vitamin D treatment and reduction of liver involvement severity in patients with non-alcoholic liver
Public title
relationship between vitamin D treatment with liver involvement severity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
vitamin D deficiency
patients suffered from non- alcoholic fatty liver disease
Exclusion criteria:
alcohol consumption history
positive HBS Ag
auto immunize hepatitis
cancers
melitus diabetics
thyroid disease
chronic kidney disease
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Research & Technology Dept, Central Building No. 2, Third Floor, Tabriz University of Medical Sciences, Golghast St, Tabriz
City
tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2019-01-21, 1397/11/01
Ethics committee reference number
IR.TBZMED.REC.1397.871
Health conditions studied
1
Description of health condition studied
non alcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Grade ultrasound
Timepoint
At the beginning of the study, 4 months
Method of measurement
Sonography
2
Description
vitamin D
Timepoint
At the beginning of the study, 4 months
Method of measurement
blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: vitamin D 50000 weekly for 4 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Teaching Hospital of Tabriz
Full name of responsible person
Manuchehr khoshbaten MD
Street address
Golgasht street, Tabriz
City
tabriz
Province
East Azarbaijan
Postal code
59-3347054
Phone
+98 41 3334 7054
Email
info@imamreza.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ata Mahmoudpour
Street address
Golgasht street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 7459
Email
medfac@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
Niloofar Rabienejad
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Golgasht street, Tabriz
City
tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3382 2082
Email
niloorabi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Niloofar Rabienejad
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Golgasht street, Tabriz
City
tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3382 2082
Email
niloorabi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Niloofar Rabienejad
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Golgasht street, Tabriz
City
tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3382 2082
Email
niloorabi@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
Undecided - It is not yet known if there will be 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