The purpose of this study is to evaluate the effect of vitamin D deficiency therapy on enzymatic activity in patients with nonalcoholic fatty liver. Major inclusion criteria and exclusion criteria: inclusion criteria include patients who have been referred to the gastroenterology clinic with increased liver enzymes and have been diagnosed with non-alcoholic fatty liver by surveys and sonography findings, patients with vitamin D levels below 30 ng/ml, Exclusion criteria include drug abuse, the use of vitamins (multivitamin, vitamin C and vitamin D) in the last 6 months and during the study, weight loss is more than 5% within 6 months before entering the study. Design: This study was designed as a randomized, Single-blind clinical trials. In this study, 80 patients with non-alcoholic fatty liver after completing the consent form will be included in the study and randomly (randomized block method) divided into 2 groups. Interventions: Intervention group: Patients will receive 50000 IU Pearl vitamin D3 once a week for a period of 12 weeks and will also provide recommendations for improving their lifestyle through regular exercise and setting a daily diet plan (Low Fat and Low Carb) and The control group will receive only lifestyle modification program (regular exercise and diet planning). Patients will be followed up for 12 weeks. Main outcome variables: Primary outcome variables: Serum levels of hepatic enzymes including alanine aminotransferase and aspartate aminotransferase and secondary outcome variables: weight of patients, lipid profiles and vitamin D3 levels
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017102218124N5
Registration date:2017-11-20, 1396/08/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-11-20, 1396/08/29
Registrant information
Name
Ali Akbar Hajiaghamohammadi
Name of organization / entity
Metabolic Diseases Research Center, Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3336 0084
Email address
ahmohammadi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Qazvin University of Medical Sciences
Expected recruitment start date
2017-11-21, 1396/08/30
Expected recruitment end date
2018-03-11, 1396/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D supplementation on serum Liver enzymes in patients with Non-Alcoholic Fatty Liver Disease
Public title
The effect of vitamin D deficiency treatment on the improvement of patients with fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Older than 12 years of age; high levels of liver enzymes over the past six months (ALT > 40 U/L); serum vitamin D3 level less than 30 ng/ml; diagnosis to have nonalcoholic fatty liver disease confirmed with sonography results; having non-alcoholic fatty liver disease (NAFLD) and rule out of other hepatic-enzymes rising causes such as viral and autoimmune hepatitis and other chronic liver diseases such as hereditary hemochromatosis, Wilson's disease, an α1- Antitripsin enzyme deficiency; pharmaceutical Hepatitis; consumption of Alcohol.
Exclusion Criteria: Pregnancy or lactation; drug abuse; the use of vitamins (multivitamin, vitamin C and vitamin D) in the last 6 months and during the study; weight loss more than 5% during the 6 months before entering the study; diabetes; use of anti-obesity drugs; hypercalcemia; chronic kidney disease; cardio-pulmonary disease; hyperlipidemia which needs medications and Drugs; malignant history; history of the use of effective drugs on the level of ALT such as Valproic acid, Tamoxifen, HMG-COA reductase inhibitors; chemotherapy compounds; Metformin; Statins; Azathioprine; Acetaminophen; antibiotics such as Sulfanamide and Penicillins; Amiodaron; Methotrexate; Isoniazid; Steroids; herbal Medicines; Ursodeoxycholic acid at 3 months before.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Comitte of Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd, Qazvin.
City
Qazvin
Postal code
3419759811
Approval date
2017-04-18, 1396/01/29
Ethics committee reference number
IR.QUMS.REC.1396.5
Health conditions studied
1
Description of health condition studied
Nonalcoholic fatty liver disease
ICD-10 code
K75.8
ICD-10 code description
Other specified inflammatory liver diseases
Primary outcomes
1
Description
hepatic enzymes (aminotransferase)
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Measuring the activity of enzymes in serum
Secondary outcomes
1
Description
Lipid profiles
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
Biochemical method
2
Description
Serum level of vitamin D3
Timepoint
At the beginning of the study and 12 weeks after the intervention
Method of measurement
RadioImmuno Assay method
Intervention groups
1
Description
Intervention group: Patients will receive 50000 IU Pearl vitamin D3 once a week for a period of 12 weeks and will also provide recommendations for improving their lifestyle through regular exercise and setting a daily diet plan (Low Fat and Low Carb).
Category
Treatment - Drugs
2
Description
The control group will receive only lifestyle modification program (regular exercise and diet planning)
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat educational and treatment center
Full name of responsible person
Dr. Aliakbar Hajiaghamohammadi
Street address
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Qazvin University of Medical Sciences
Full name of responsible person
Dr. Amir Peymani
Street address
Qazvin, Shahid Bahonar Blvd.
City
Qazvin
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 of Qazvin University of Medical Sciences