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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-008275-34 | EudraCT Number |
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| Name | Class |
|---|---|
| NHS Lothian | OTHER_GOV |
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There is preliminary evidence that Omega 3, a compound naturally found in fish oil, reduces the amount of fat stored in the liver and improves liver function. The purpose of this study is to see whether this observation is correct.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omacor | Active Comparator |
| |
| Lactose tablet | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omacor | Drug | Active comparator: omacor 4g/day |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Liver appearance on ultrasound | The primary endpoint is improvement in grading on ultrasound assessment at six months. Liver brightness and posterior attenuation on ultrasound has previously been shown to correlate significantly with fat scores on liver biopsy. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Liver function tests | the effect of omega-3 fatty acids on serum liver function tests will be assessed following 6 months of treatment. | 6 months |
| hepatocyte mitochondrial function | heptocyte mitochondrial function will be measured by breath testing following 6 months of omega-3 supplementation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter C Hayes, MD PhD | Royal Infirmary of Edinburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Infirmary of Edinburgh | Edinburgh | Lothian | EH164SA | United Kingdom |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C405603 | Omacor |
| D004281 | Docosahexaenoic Acids |
| D015525 | Fatty Acids, Omega-3 |
| D007785 | Lactose |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| lactose tablet | Drug | placebo: lactose tablet 4g/day |
|
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| 6 months |
| Health-related Quality of Life | Health related quality of life scores will be compared with baseline following 6 months of omega-3 supplementation | 6 months |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |