The effect of folate supplementation on serum hepatic enzymes, lipid profile and homocystein levels in patients with Non-Alcoholic Fatty Liver Disease: A Randomized Controlled trial
The aim of the study is evaluation of the effect of folate supplementation on serum hepatic enzymes, lipid profile and homocystein levels in patients with Non-Alcoholic Fatty Liver Disease. Study design is double blind placebo controlled randomized clinical trial. The study sample includes 40 male patients (20 in intervention and 20 in control group) diagnosed with non alcoholic fatty liver disease. Inclusion Criteria : diagnosis to have non alcoholic fatty liver disease, ages above 18 and serum alanine transaminase enzyme level higher than 30 U/L . Exclusion criteria: Alcohol consumption greater than 20 g per day, having other hepatic diseases, using hepatotoxic drugs and consumption of folate, B12, vitamin E and omega-3 supplementation during last 6 months. Intervention: One tablet of folate supplement contains 1 mg folic acid will be prescribed daily for 8 weeks in intervention group. One tablet placebo contains starch will be prescribed daily for 8 weeks in control group. Primary Outcomes: Serum levels of alanine transaminase and grade of fatty liver based on ultrasonography. Secondary Outcomes: serum levels of lipid profile and homocystein.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015051710333N2
Registration date:2015-10-27, 1394/08/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-27, 1394/08/05
Registrant information
Name
Nasrin Sharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5562 0608
Email address
sharifi.n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ilam University Of Medical Sciences
Expected recruitment start date
2015-10-17, 1394/07/25
Expected recruitment end date
2015-12-16, 1394/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of folate supplementation on serum hepatic enzymes, lipid profile and homocystein levels in patients with Non-Alcoholic Fatty Liver Disease: A Randomized Controlled trial
Public title
The effect of folate supplementation on Non Alcoholic Fatty Liver Disease treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Diagnosis to have non alcoholic fatty liver disease confirmed with ultrasonography result; ages above 18 ; serum alanine transaminase enzyme level higher than 30 U/L ; Diabetic patients will include if they have been recently diagnosed with diabetes and not using blood glucose lowering drugs or if they consume insulin and metformin, it would pass at least 6 months from starting the treatment and during this period the dose of metformin and insulin are not changed. Exclusion criteria: Alcohol consumption greater than 20 g per day; diseases such as hereditary hemochromatosis; Wilson's disease; an enzyme deficiency α1 Antitripsin; history of jejunoileal bypass surgery or gastroplasty; experience to perform the total parenteral nutrition at 6 months before; consomption of statins and hepatotoxic drugs such as calcium channel blocker; methotrexate; amiodarone; chloroquine; a history of hypothyroidism and Cushing's syndrome; Intake of folate; B12; vitamin E; omega-3 supplements during last 6 months.
Age
From 18 years old to 65 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ilam University of Medical Sciences
Street address
Ilam University of Medical Sciences, Pajoohesh Blvd.
City
Ilam
Postal code
Approval date
2015-09-29, 1394/07/07
Ethics committee reference number
IR.MEDILAM.REC.1394.285
Health conditions studied
1
Description of health condition studied
Non alcoholic fatty liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver
Primary outcomes
1
Description
Serum Alanine Transaminase
Timepoint
Before and after intervention
Method of measurement
U/L - Laboratory kit
2
Description
Grade of fatty liver based on ultrasonography results
Timepoint
Before and after intervention
Method of measurement
Ultrasonography scan
Secondary outcomes
1
Description
Serum Total cholestrol
Timepoint
Before and after intervention
Method of measurement
mg/dL - Laboratory kit
2
Description
Serum LDL-C
Timepoint
Before and after intervention
Method of measurement
mg/dL- laboratory kit
3
Description
Serum HDL-C
Timepoint
Before and after intervention
Method of measurement
mg/dL- laboratory kit
4
Description
Serum Homocystein
Timepoint
Before and after intervention
Method of measurement
Laboratory kit-umol/Liter
5
Description
Serum Triglyceride
Timepoint
Before and after intervention
Method of measurement
mg/dL- Laboratory kit
6
Description
Serum Aspartate Transaminase (AST)
Timepoint
Before and after intervention
Method of measurement
U/L- laboratory kit
Intervention groups
1
Description
Intervention: Tablet contains 1 mg folate, once a day for 8 weeks
Category
Treatment - Drugs
2
Description
Control: One placebo tablet contains edible starch, once a day for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical Clinic of Ilam Petrochemical Company
Full name of responsible person
Dr. Gharib Reza Younessi
Street address
Ilam Petrochemical Company, Chavar, Ilam
City
Ilam
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Dr. Behzad Badakhsh
Street address
Vice Chancellor for Research and Technology, Ilam University of Medical Sciences
City
Ilam
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Vice Chancellor for Food and Drug, Ilam University of Medical Sciences
Full name of responsible person
Soheila Samieepour
Position
MSc / Expert of food staff and beverages
Other areas of specialty/work
Street address
Vice Chancellor for Food and Drug, IlamUniversity of Medical Sciences, Shahid Keshvari Sq.
City
Ilam
Postal code
Phone
+98 84 3223 2523
Fax
Email
sarma1364@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Nasrin Sharifi
Position
Ph.D / Assistant Professor of Nutrition Sciences
Other areas of specialty/work
Street address
Faculty of Medicine, Kashan University of Medical Sciences, Ghotb Ravandi Blvd
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
sharifi.nsr@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Vice Chancellor for Food and Drug, Ilam University of Medical Sciences
Full name of responsible person
Soheila Samieepour
Position
MSc / Expert of food staff and beverages
Other areas of specialty/work
Street address
Vice Chancellor for Food and Drug, Ilam University of Medical Sciences, Shahid Keshvari Sq.
City
Ilam
Postal code
Phone
+98 84 3223 2523
Fax
Email
sarma1364@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)