Comparison of the effect of vitamin B12 supplement with placebo on grade of liver steatosis and fibrosis based on the results of elastography in patients with Non-Alcoholic Fatty Liver Disease

Comparison of the effect of vitamin B12 supplement with placebo on grade of liver steatosis and fibrosis based on the results of elastography in patients with Non-Alcoholic Fatty Liver Disease

A randomized controlled clinical trial with parallel design. Total sample size will be 40 and randomization will be done based on the sequences of the random blocks using statistical software.

Patients with fatty liver disease will be evaluated for the study inclusion criteria at the gastroenterology clinic of Kashan University of Medical Sciences. Liver elastography, anthropometric indices and biochemical tests measured at baseline and after the intervention.

Inclusion criteria: Patients who are diagnosed to have non alcoholic fatty liver disease confirmed with ultrasonography result; Ages between 18-80 years; Serum alanine transaminase enzyme level higher than 30 U/L in men and higher than 19 U/L in women. Exclusion criteria: Pregnancy; Lactation; Alcohol consumption; Having diseases such as hereditary hemochromatosis, Wilson's disease and α1 antitripsin enzyme deficiency; History of jejunoileal bypass surgery and history of receiving total parenteral nutrition during last 6 months; Consumption of statins and hepatotoxic drugs such as calcium channel blocker, methotrexate, amiodarone, chloroquine; Intake of folate, B12, vitamin E and omega-3 supplements during the last 3 months

The intervention group will receive one tablet contains 1000 microgram vitamin B12 daily for 12 weeks. The control group will receive one tablet of placebo daily for 12 weeks.

A change in grade of liver steatosis and fibrosis; changes in serum levels of alanine transaminase and aspartate transaminase; change in insulin resistance; changes in serum levels of malondialdehyde and C-reactive protein

The change in the device of assessing hepatic steatosis and fibrosis

Participants will be randomly assigned to the intervention or control group in the random blocks based on the random number table. The sequence of permuted blocks will be generated with a random number table. An individual with no clinical involvement in the trial, puts the lable of intervention or control group in an opaque and sealed envelope based on the random sequence. Then the other person, who is not aware of random sequences and the envelope content, will assign the patients to the intervention or control group.

In the present study, participants, clinical caregiver, principal investigator, data analyzer and outcome evaluator will be blinded to the allocation to study groups.

A portion of the data regarding demographics, anthropometric, and food variables, that are collected at the baseline of the study, and also the information on the main outcome will be shared.

The start of the data access period will be one year after the publication of the results

Researchers working in academic institutions

In order to conduct meta-analysis studies

Nasrin Sharifi, Nutrition Department, School of Medicine, Kashan University of Medical Sciences, Qotbe-e-Ravandi Blvd., Kashan, Iran Postal Code: 88715973474 E-mail: sharifi-na@kaums.ac.ir Tel: 00983155540021 Fax: 00983155620608

An applicant can send a request for a data file by e-mail. After reviewing the request, the data file will be sent to him/her after about three weeks would have passed from the date of the request.