Objectives:This study was performed to evaluate the efficacy of Vitamin D in nonalcoholic fatty liver disease (NAFLD) patients.Design: Study sample were patients who had elevated liver enzymes and referred to subspecialized gastrointestinal clinic and diagnosed as NAFLD with conducted assessment.The patients whoose level vitamin D less than 30 nanogram endrolled. At first, fibroscan will be performed for all of patients. The intervention group (20 individuals) will receive 50000International Unit vitamin D in each week for 12 weeks, besides lifestyle modification with daily nutritional program, daily energy regulation on 2000 calorie in females and 2500 calorie in males. The control group will receive only lifestyle modification program.Two groups will be matched with random number table. The patiens weight and length will be measured with digital Seca scale. Two groups will be matched about age,gender ,body mass index and the severity of fatty liver disease. The patients will be followed up for 6 months: Body Mass Index and the level of aminotransferase will be checked, and fibroscan will be performed and the results will be compared within two groups.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015102624725N1
Registration date:2016-01-03, 1394/10/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-03, 1394/10/13
Registrant information
Name
Tarang Taghvaei
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3335 0670
Email address
gi-research-1@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Mazandaran University of Medical Sciences
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of vitamin D administration in non-alchoholic fatty liver disease(NAFLD)
Public title
The efficacy of vitamin D administration in non-alchoholic fatty liver disease(NAFLD)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: ALT rising equals or more than 2times of normal level; probable diagnosis of Nonalcoholic Steatohepatitis and rule out of other hepatic-enzymes rising causes such as viral and autoimmune hepatitis; age more than 18 years; serum vitamin D level less than 30 nanogram per mililiter
Exclusion Criteria:
hepatic cirrhosis; pregnancy or breast-feeding; alcohol use ; substance abuse;vitamin D administration in 6 months ago, weight loss more than 5% in 1 year ago; newly-diagnosed diabetes (in the recent 1 year) which needs treatment: antioverweight medication ; hypercalcemia; chronic renal disease; life-threatening cardiopulmonary diseases ; hyperlipidemia which needs medication; medications which affect on hepatic enzymes
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)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Two groups will be matched with random number table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Vice chancellor of research, Unit number 2, Moallem Square, Sari
City
Sari
Postal code
Approval date
2015-05-13, 1394/02/23
Ethics committee reference number
1144
Health conditions studied
1
Description of health condition studied
Nonalcoholic fatty liver disease (NAFLD)
ICD-10 code
K76.0
ICD-10 code description
Nonalcoholic fatty liver disease (NAFLD
Primary outcomes
1
Description
the level of aminotransferases
Timepoint
3th and 6th month
Method of measurement
biochemical
2
Description
Fibroscan and BMI
Timepoint
3th and 6th month for BMI and 6th month for fibroscan
Method of measurement
fibroscan and anthropometric measurement( kg/m2)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention:administration of vitamin D pearl and life style modification
Category
Treatment - Drugs
2
Description
Control: lifestyle modification
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hospital
Full name of responsible person
Tarang Taghvaei
Street address
Imam Hospital, Amir Mazandarani Avenue, Sari
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Sari, Moallem Square, Unit number 2, Vice chancellor of research
City
Sari
Grant name
معاونت پژوهشی دانشگاه علوم پزشکی مازندران
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Tarang Taghvaei
Position
Assisstant Professor
Other areas of specialty/work
Street address
Imam Hospital, Sari
City
Sari
Postal code
Phone
+98 11 3335 0670
Fax
Email
Tarang_taghvaei@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Tarang Taghvaei
Position
Subspecialist in GI disorders
Other areas of specialty/work
Street address
Imam Hospital, Sari
City
Sari
Postal code
Phone
+98 11 3335 0670
Fax
Email
Tarang_taghvaei@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Tarang Taghvaei
Position
Subspecialist in GI disorders
Other areas of specialty/work
Street address
Imam Hospital, Sari
City
Sari
Postal code
Phone
+98 11 3335 0670
Fax
Email
Tarang_taghvaei@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)