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
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SLCTR Registration Number
SLCTR/2017/033
Date of Registration
The date of last modification
Aug 24, 2019
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)
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
Male and female patients aged 18-60 years.
Ultrasonographic evidence of fatty liver (Increased hepatic echogenicity compared to the kidneys or the spleen)
Raised ALT (more than 30U/L for males, more than 19 U/L for females)
Exclusion criteria
Primary outcome(s)
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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) ] |
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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
2018-01-01
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
None (Investigator funded)
Regulatory approvals
Not applicable
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 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/
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
