Objectives: Prescribing Flaxseed oil on the non invasive liver marker's in patients with non-alcoholic fatty liver disease.
Design: Interventional- Not blinded. The major inclusion criteria are:
The enzyme Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) at least 1.5 times above the normal limit, confirmed by the kidney sonography; Meeting at least one of the following criteria: Within the age range of 15-60 years old, diabetes, Hyperlipidemia, and Obesity.
The major exclusion criteria are as follows:
Consuming alcohol or having a history of drinking problems; Positive serology for viral hepatitis (C , B); Positive Anti-Nuclear Antibody (ANA) or Anti-Mitochondrial Antibodies (AMA) tests, Alpha-1 antitrypsin; Reduced serum levels of ceruloplasmin or increasing levels of Anti-smooth muscle (ASMA) and Liver kidney microsomal type 1 antibody (LKM1) antibodies; Ferritin level larger than 450, or Iron and Total iron binding capacity (IRON/TIBC) less than 45%; The patients being diagnosed with acute or chronic illnesses which cause disorders in LFT (liver function tests), before or during the medical intervention; the patients’ consumption of drugs, before or during the medical intervention, which cause disorders in LFT; Pregnancy; Age less than 15 or above 60 years.
Target sample size: 60 people
Intervention group: Oral Flaxseed every day 3 times (1 gr) for 2 months; Control group: Oral E Vitamin 3 times a day for 2 months. Main outcome measure: Liver Enzyme ( at the admission and 2 months after applying the intervention).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013111715427N1
Registration date:2014-01-21, 1392/11/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-21, 1392/11/01
Registrant information
Name
Ali Beheshti Namdar
Name of organization / entity
Imam Reza Hospital
Country
Iran (Islamic Republic of)
Phone
+98 915 110 8122
Email address
beheshtia901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Mashhad University of Medical Medicine
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-01-21, 1392/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effects of flaxseed oil and vitamin E on non-invasive markers of liver in patients with nonalcoholic fatty liver disease.
Public title
Comparative effects of flaxseed oil and vitamin E on non-invasive markers of liver in patients with nonalcoholic fatty liver disease.
Purpose
Treatment
Inclusion/Exclusion criteria
The major inclusion criteria are:
The enzyme Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) at least 1.5 times above the normal limit, confirmed by the kidney sonography; Meeting at least one of the following criteria: Within the age range of 15-60 years old, diabetes, Hyperlipidemia, and Obesity.
The major exclusion criteria are as follows:
Consuming alcohol or having a history of drinking problems; Positive serology for viral hepatitis (C , B); Positive Anti-Nuclear Antibody (ANA) or Anti-Mitochondrial Antibodies (AMA) tests, Alpha-1 antitrypsin; Reduced serum levels of ceruloplasmin or increasing levels of Anti-smooth muscle (ASMA) and Liver kidney microsomal type 1 antibody (LKM1) antibodies; Ferritin level larger than 450, or Iron and Total iron binding capacity IRON/TIBC less than 45%; The patients being diagnosed with acute or chronic illnesses which cause disorders in LFT (liver function tests), before or during the medical intervention; the patients’ consumption of drugs, before or during the medical intervention, which cause disorders in LFT; Pregnancy; Age less than 15 or above 60 years.
Age
From 15 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
the patients are randomly (and equally) divided into two groups, based on the table of random numbers; one group is administered Flaxseed oil and the other receives E vitamin
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Mashhad University of Medical Sciences
Street address
Vice Chancellor for research of Mahhad University of Medical Sciences, Daneshgah Street, Ghoreishi Building, Mashhad
City
Mashhad
Postal code
Approval date
2013-02-20, 1391/12/02
Ethics committee reference number
910677/1/24
Health conditions studied
1
Description of health condition studied
Nonalcoholic fatty liver
ICD-10 code
K76.0
ICD-10 code description
Nonalcoholic fatty liver disease
Primary outcomes
1
Description
Liver Enzyme
Timepoint
Admission and 2 months after applying the intervention
Method of measurement
Blood Sampling
Secondary outcomes
1
Description
Blood Glucose
Timepoint
Admission and 2 months after applying the intervention
Method of measurement
Blood Sampling
Intervention groups
1
Description
Intervention group: Oral Flaxseed
every day 3 times (1 gr) for 2 months
Category
Treatment - Drugs
2
Description
Control group: E Vitamin, Oral capsule, 3 times a day for 2 months