Effects of Vitamin E Delta-tocotrienol supplementation in Nonalcoholic Fatty Liver Disease (NAFLD)
Phase 2
Recruiting
- Conditions
- onalcoholic fatty liver disease (NAFLD)
- Registration Number
- SLCTR/2015/023
- Lead Sponsor
- Armed Forces Institute of Pathology, Pakistan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
1. Patients of both genders aged 20 years and above.
2. Ultrasound-proven fatty liver
3. Fatty Liver Index (FLI) score of equal to or more than 60
4. Mild to moderate elevation of alanine transaminase (ALT) and aspartate transaminase (AST) i.e. not greater than four times the upper limit of 42 IU/L and 37 IU/L respectively
Exclusion Criteria
1. Chronic hepatitis B and C
2. Alcoholic fatty liver disease
3. Any other acute or chronic illness including cancer
4. Autoimmune liver disease
5. Patients receiving other medications including herbal or vitamin supplements
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. 40% reduction in Fatty Liver index (FLI) score from the baseline value<br>2. 25% reduction in insulin resistance (IR) calculated by Homeostasis Model Assessment (HOMA)<br> [At baseline,12 weeks and 24 weeks (end of trial)]<br>
- Secondary Outcome Measures
Name Time Method 1. 40% reduction in High-sensitivity C-reactive protein (hs-CRP), Malondialdehyde (MDA), Alanine transaminase (ALT) and Aspartate transaminase (AST) from the baseline values <br><br>2. Grading of NAFLD on ultrasonography<br> [At baseline,12 weeks and 24 weeks(end of trial)]<br>