Effect of Omega 3 Fatty Acid supplementation on hepatic steatosis and liver stiffness in patients with nonalcoholic fatty liver disease: a Randomized Controlled Trial
- Conditions
- onalcoholic fatty liver disease (NAFLD)
- Registration Number
- SLCTR/2017/033
- Lead Sponsor
- Department of Hepatology,Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Not specified
- Target Recruitment
- Not specified
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)
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method iver stiffness measurement (LSM) as determined by fibroscan of liver [At baseline and 6 months after the commencement of the intervention (end of treatment)]<br>Hepatic steatosis with controlled attenuation parameter (CAP) [At baseline and 6 months after the commencement of the intervention (end of treatment)]<br>
- Secondary Outcome Measures
Name Time Method