Home » Trials » SLCTR/2017/033


Effect of Omega 3 Fatty Acid supplementation on hepatic steatosis and liver stiffness in patients with nonalcoholic fatty liver disease: a Randomized Controlled Trial

-

SLCTR Registration Number

SLCTR/2017/033


Date of Registration

28 Sep 2017

The date of last modification

Jan 28, 2019



Application Summary


Scientific Title of Trial

Effect of Omega 3 Fatty Acid supplementation on hepatic steatosis and liver stiffness in patients with nonalcoholic fatty liver disease: a Randomized Controlled Trial


Public Title of Trial

Effect of Omega 3 Fatty Acid supplementation on hepatic steatosis and liver stiffness in patients with nonalcoholic fatty liver disease: a Randomized Controlled Trial


Disease or Health Condition(s) Studied

Nonalcoholic fatty liver disease (NAFLD)


Scientific Acronym

None


Public Acronym

None


Brief title

Effect of Omega 3 Fatty Acid supplementation on hepatic steatosis and liver stiffness in patients with nonalcoholic fatty liver disease.


Universal Trial Number

U1111-1199-4433


Any other number(s) assigned to the trial and issuing authority

BSMMU/2017/6068 (IRB: Bangabandhu Sheikh Mujib Medical University)


Trial Details


What is the research question being addressed?

Does Omega 3 Fatty Acid supplementation has any effect on hepatic steatosis and liver stiffness in patients with nonalcoholic fatty liver disease?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Supportive care


Study Phase

Not Applicable


Intervention(s) planned

Patients attending outpatient department of Hepatology, Bangabandhu Sheikh Mujib Medical University (BSMMU) with sonological evidence of fatty liver will be recruited. Participants meeting inclusion and exclusion criteria will be allocated to the study arms using simple randomization (lottery technique).

The intervention arm will receive Omega 3 Fatty Acids (Omega-3- acid Ethyl Esters) 1g capsule to be taken orally, twice daily for 6 months. This will be on top of standard management according to guidelines (AASLD guidelines diagnosis and managements of non- alcoholic fatty liver disease, 2012).

The control arm will receive standard management only, according to the above guidelines.

All participants will receive standard management for diabetes, dyslipidaemia, hypertension etc. as indicated, and according to standard guidelines.


Inclusion criteria

  1. Male and female patients aged 18-60 years.

  2. Ultrasonographic evidence of fatty liver (Increased hepatic echogenicity compared to the kidneys or the spleen)

  3. Raised ALT (more than 30U/L for males, more than 19 U/L for females)


Exclusion criteria

  1. History of significant alcohol intake (more than 30 gm/day in males and more than 20 gm/day in females)
  2. History of taking drugs
    a. Drugs that may cause fatty liver (i.e. tamoxifen, valproate, amiodarone, methotrexate)
    b. Concomitant drugs: Vitamin E, statins, metformin, Silymarin.
  3. Chronic viral hepatitis (hepatitis B virus and Hepatitis C virus) as determined by serological investigations – HBs Ag, Anti HBc(T), Anti HCV
  4. Known and overt case of any other liver diseases, Wilson’s disease (by Serum Ceruloplasmin), autoimmune liver diseases(by Anti Nuclear antibody), hemochromatosis, cirrhosis of liver (other than NASH).
  5. Pregnancy
  6. Diagnosed psychiatric disorders.
  7. Recent Myocardial infarction, liver failure or hypothyroidism.
  8. Diagnosed co-morbid conditions (Cronic obstructive pulmonary disease,chronic renal failure, cardiac failure etc).


Primary outcome(s)

  1. Liver stiffness measurement (LSM) as determined by fibroscan of liver

    [

    At baseline and 6 months after the commencement of the intervention (end of treatment)

    ]
  2. Hepatic steatosis with controlled attenuation parameter (CAP)

    [

    At baseline and 6 months after the commencement of the intervention (end of treatment)

    ]

Secondary outcome(s)

  1. Blood pressure (using standardized mercury sphygmomanometer and measurement techniques)

    [

    At baseline and 6 months after the commencement of the intervention (end of treatment)

    Note: FBS, 2HABF & HbA1c and Lipid profile will be done at baseline, then monthly for 3 months and at the end of 6 months for patients with diabetes and dyslipiaemia

    ]
  2. Anthropometric parameters: waist circumference and body mass index (BMI)

    [

    At baseline and 6 months after the commencement of the intervention (end of treatment)

    ]
  3. Liver functions tests as determined by serum alanine transaminase (ALT), aspartate transaminase (AST), gamma glutamyl transpeptidase (GGT)

    [

    At baseline and 6 months after the commencement of the intervention (end of treatment)

    ]
  4. Lipid profile as determined by total cholesterol (TC), triglycerides (TG), high density lipoproteins (HDL) and low density lipoproteins (LDL)

    [

    At baseline and 6 months after the commencement of the intervention (end of treatment)

    Lipid profile will be done at baseline, then monthly for 3 months and at the end of 6 months for patients with diabetes and dyslipiaemia

    ]
  5. Metabolic parameters: fasting blood sugar (FBS), blood sugar 2 hours after breakfast (2HABF), glycosylated haemoglobin (HbA1c), beta cell function using HOMA-IR (homeostasis model assessment – insulin resistance)

    [

    At baseline and 6 months after the commencement of the intervention (end of treatment)

    FBS, 2HABF & HbA1c will be done at baseline, then monthly for 3 months and at the end of 6 months for patients with diabetes and dyslipiaemia

    ]

Target number/sample size

100 (50 in each arm)


Countries of recruitment

Bangladesh


Anticipated start date

2017-10-01


Anticipated end date

2018-08-31


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

None (Investigator funded)


Regulatory approvals

Not applicable



State of Ethics Review Approval


Status

Approved


Date of Approval

2017-06-08


Approval number

BSMMU/2017/6068


Details of Ethics Review Committee

Name: Institutional Review Board of Bangabandhu Sheikh Mujib Medical University
Institutional Address: Shahbag, Dhaka, Bangladesh
Telephone: +880-8612550
Email: registrar@bsmmu.edu.bd


Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. Muhammad Abedur Rahman Bhuyan
Resident Phase B, MD Hepatology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

+8801711700152

zimisomc@yahoo.com

Contact Person for Public Queries

Dr. MD. Shahinul Alam
Associate Professor , Department
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

+8801973007173

shahinul67@yahoo.com


Primary study sponsor/organization

Department of Hepatology,Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Resident Phase B, MD Hepatology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Dhaka 1000, Bangladesh
+8801711700152


http://www.bsmmu.edu.bd/

Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

Not Available


Study protocol available


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results