Protocol summary

Summary
In a clinical trial study, the therapeutic effect of Melatonin, Metformin and Vitamin E in patients with non-alcoholic fatty liver disease (NAFLD) dietary regimen are assessed. Participants were adults with NAFLD diagnosed by increased alanine aminotransferase (ALT), Aspartate Aminotransferase (AST) and liver ultrasound who did not have other liver diseases, including viral (hepatitis B or C), autoimmune hepititis and genetic conditions (hemochromatosis) or other liver disorders. At the first, the weight, height and waist and hip circumferences and biochemical blood serum assessment including blood sugar 2 hours after food (BS 2hpp), gamma-glutamyl transferase (GGT), Ceruloplasmin, Alkaline phosphatase (ALKP), C-reactive protein (CRP), factors of ALT, AST, fasting blood sugar (FBS), hemoglobin A1C, triglyceride (TG), Total Cholesterol, Ferritin are measured. Patients are randomly placed to three groups by sealed envelop method. One group will be received Melatonin tablet (10 mg) once a day for 30 minutes before sleep with their diet regiment for a period of 3 months. The second group will be received Metformin tablet (500 mg) once a day with their diet for a period of 3 months. The third group will be received Vitamin E tablet (800 IU, natural form) once a day with their diet for a period of 3 months. Patients are followed according to the scheduling program for a period of 3 months, and taking the correct medication, side effects, loss of individual samples and unwillingness to continue treatment are examined. After three months of intervention, measuring weight, waist, hip circumferences and biochemical blood serum test are performed again.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016040318124N3
Registration date: 2017-04-28, 1396/02/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-04-28, 1396/02/08
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, Qazvin University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the therapeutic effect of Melatonin, Metformin and Vitamin E on liver function, sugar and lipid factors in patients with non-alcoholic fatty liver disease (NAFLD) dietary regimen
Public title
The therapeutic effect of Melatonin, Metformin and Vitamin E in patients with non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having non-alcoholic fatty liver disease (NAFLD) without other liver diseases. Exclusion criteria: Alcohol consumption of more than 20 gr per day for women or more than 30 gr in men for at least 3 consecutive months during a recent 5 year period, Patients with autoimmune hepatitis, hepatitis B, hepatitis C and other chronic liver diseases, Patients with heart failure (New York Heart Association class II to IV), Patients taking drugs that cause osteo-hepatitis like fibrates, statins, NSAID, Amiodarone, and Tamoxifen, Patients with proven diabetes mellitus under medical therapy, Patients receiving vitamin C, zinc and selenium or antioxidant agents during a recent three months, Patients with kidney disease and kidney failure or any patients with GFR less than 60.
Age
From 20 years old to 50 years old
Gender
Both
Phase
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
Ethics committee of Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd.
City
Qazvin
Postal code
Approval date
2015-12-09, 1394/09/18
Ethics committee reference number
IR.QUMS.REC.1394.218

Health conditions studied

1

Description of health condition studied
Nonalcoholic fatty liver disease [NAFLD]
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified

Primary outcomes

1

Description
liver function tests
Timepoint
Before treatment and 3 months later
Method of measurement
blood sample

Secondary outcomes

1

Description
lipid tests
Timepoint
Before treatment and 3 months later
Method of measurement
blood sample

2

Description
sugar tests
Timepoint
Before treatment and 3 months later
Method of measurement
blood sample

Intervention groups

1

Description
Administration of melatonin (10 mg tablet) once a day with diet for a period of 3 months
Category
Treatment - Drugs

2

Description
Administration of metformin (500 mg tablet) once a day with diet for a period of 3 months
Category
Treatment - Drugs

3

Description
Administration of vitamin E (800 IU tablet) once a day with diet for a period of 3 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Velayat Hospital
Full name of responsible person
Dr. Sina Khajeh Jahromi
Street address
Velayat hospital, 22 Bahman Blvd., Taavon square, Minoodar area, Qazvin
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Qazvin University of Medical Sciences
Full name of responsible person
Dr. Taghi Naserpoor Farivar
Street address
Shahid Bahonar Blvd, Qazvin university of medical sciences
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, Qazvin 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
Qazvin university of medical sciences
Full name of responsible person
Dr. Sina Khajeh Jahromi
Position
Internal medicine resident
Other areas of specialty/work
Street address
Velayat hospital, 22 Bahman Blvd., Taavon square, Minoodar area, Qazvin
City
Qazvin
Postal code
Phone
+98 28 3333 7006
Fax
Email
sina.khajehjahromi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Ali Akbar Hajiaghamohammadi
Position
Associate Professor
Other areas of specialty/work
Street address
Shahid Bahonar Blvd, Qazvin University of Medical Sciences
City
Qazvin
Postal code
Phone
+98 28 3333 7006
Fax
Email
ahmohammadi@qums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Sina Khajeh Jahromi
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Shahid Bahonar Blvd, Qazvin University of Medical Sciences
City
Qazvin
Postal code
Phone
+98 28 3333 7006
Fax
Email
sina.khajehjahromi@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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