This study tries to compare between the active and non-active forms of Vitamin D in improving non-alcoholic fatty liver disease. 90 patients are selected by a gastroenterologist after their diseases diagnosis and having study entrance inclusion criteria. All patients will sign the satisfaction form. Initially the patients' vitamin D level, fat profile and their liver enzymes of ALT and AST will be measured and registered.
The patients will be selected randomly and they are divided into three groups of 30 each through permutation blocks.
First group: receiving medication (Rocaltrol) capsules (soft gel) 1mcg/day
Second group: receiving medication (vitamin D3) capsules (soft gel) 50000UI/week
Third group: control
The patients use the drugs for 8 weeks and then the primary experiments will be repeated and recorded.
ANOVA will be used to compare the results of liver enzymes and fat profile in three groups and if there is a difference among three groups the post hoc test is used to compare them.
General information
Acronym
Non Alcoholic Fatty Liver(NAFLD)
IRCT registration information
IRCT registration number:IRCT2015010720595N1
Registration date:2015-11-16, 1394/08/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-16, 1394/08/25
Registrant information
Name
Zahra Almoosavi
Name of organization / entity
Shiraz School of Pharmacy
Country
Iran (Islamic Republic of)
Phone
+98 71 3242 4128
Email address
moosaviz@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences, Shiraz School of Pharmacy
Expected recruitment start date
2015-08-02, 1394/05/11
Expected recruitment end date
2015-10-07, 1394/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comprasion Of Active and Inactive Vit D On Non Alcoholic Fatty Liver(NAFLD)
Public title
The comprasion Of Active and Inactive Vit D On Non Alcoholic Fatty Liver(NAFLD)
Purpose
Treatment
Inclusion/Exclusion criteria
The study inclusion criteria: the patients by NAFLD (non-alcoholic fatty liver disease) definition; age>18 years old; patient's cooperation.
The study exclusion criteria: any liver disease except for NAFLD; alcohol consumption and any addictive drugs; lactating or pregnant patients; noncooperation or dissatisfaction of the patient; any drug consumption that may affect NAFLD.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
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
Shiraz School of Pharmacy
Street address
Shiraz School of Pharmacy, Karafarin St., Darvaze Qhoran 5 km, Roknabad ,
City
Shiraz
Postal code
7146864685
Approval date
2015-08-02, 1394/05/11
Ethics committee reference number
IR.SUMS.REC.1394088
Health conditions studied
1
Description of health condition studied
Non Alcoholic Fatty Liver
ICD-10 code
K760
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Vit D
Timepoint
Before intervention and 2 month after it
Method of measurement
Blood test
2
Description
ALT
Timepoint
Before intervention and 2 month after it
Method of measurement
Blood Test
3
Description
AST
Timepoint
Befor intervention and 2 month after it
Method of measurement
Blood test
4
Description
Lipid profile
Timepoint
Befor intervention and 2 month after it
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Group A: received medication (Rocaltrol) capsules (soft gel) 1mcg/day
Category
Treatment - Drugs
2
Description
Group B: received medication (vitD3) capsules (soft gel) 50000IU/week
Category
Treatment - Drugs
3
Description
Group C: control
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari & Faqihi clinic
Full name of responsible person
Dr. Ramin Niknam
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Ali Dehshahri
Street address
Shiraz University of Medical Sciences, 5 km Darvaze Qoran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical 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
Shiraz School of Pharmacy
Full name of responsible person
Dr. Laleh Mahmoudi
Position
Assistant Professor
Other areas of specialty/work
Street address
Shiraz School of Pharmacy, Karafarin St., 5 km Darvaze Qoran
City
Shiraz
Postal code
7146864685
Phone
+98 71 3242 4128
Fax
+98 71 3242 4126
Email
mahmoudi_l@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz School of Pharmacy
Full name of responsible person
Dr. Laleh Mahmoudi
Position
Assistant Professor
Other areas of specialty/work
Street address
Shiraz School of Pharmacy, Karafarin St., 5 km Darvaze Qoran
City
Shiraz
Postal code
7146864685
Phone
+98 71 3242 4128
Fax
+98 71 3242 4126
Email
mahmoudi-l@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz School of Pharmacy
Full name of responsible person
Dr. Laleh Mahmoudi
Position
Assistant Professor
Other areas of specialty/work
Street address
Shiraz School of Pharmacy, Karafarin St., 5 km Darvaze Qoran
City
Shiraz
Postal code
7146864685
Phone
+98 71 3242 4128
Fax
+98 71 3242 4126
Email
mahmoudi-l@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)