The effect of omega-3 in non-alcoholic fatty liver disease
| ISRCTN | ISRCTN81956288 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81956288 |
| Secondary identifying numbers | 7156 |
- Submission date
- 19/05/2010
- Registration date
- 19/05/2010
- Last edited
- 24/08/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Richard Johnston
Scientific
Scientific
Nottingham University Hospital
Wolfson Digestive Diseases Centre
C Floor, South Block QMC
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom
Study information
| Study design | Single centre randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The effect of n-3 polyunsaturated fatty acid (PUFA) supplementation in patients with steatosis due to non-alcoholic fatty liver disease |
| Study objectives | Assess the effects of a 3 month PUFA supplementation versus placebo. |
| Ethics approval(s) | Nottingham Research and Ethics Committee 1, 11/03/2008, ref: 08/H0403/14 |
| Health condition(s) or problem(s) studied | Topic: Metabolic and Endocrine; Subtopic: Metabolic and Endocrine (all Subtopics); Disease: Metabolic & Endocrine (not diabetes) |
| Intervention | 58 patients with biopsy proven steatosis due to non-alcoholic fatty liver disease (NAFLD) will be randomised to 3.5 g n-3 polyunsaturated fatty acid (PUFA) or oleic enriched sunflower oil capsules for 3 months. Follow-up length: 3 months Study entry: registration and one or more randomisations |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Fructose, glucose |
| Primary outcome measure | Hepatic steatosis as determined by magnetic resonance imaging (MRI) spectroscopy pre- and post-intervention Liver fat stores (MR spectroscopy), measured pre- and post-intervention |
| Secondary outcome measures | Measured pre- and post-intervention: 1. Liver biochemistry 2. Lipid profile 3. Insulin resistance 4. Blood pressure 5. Abdominal visceral fat 6. Inflammatory cytokine profile |
| Overall study start date | 12/01/2009 |
| Completion date | 01/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 58; UK sample size: 58 |
| Key inclusion criteria | 1. Age greater than 18 years, either sex 2. Liver biopsy showing NAFLD |
| Key exclusion criteria | 1. Excessive alcohol intake - greater than 21 units per week in men and greater than 14 in women 2. A further liver disease diagnosis 3. Poorly controlled diabetes - HbA1c greater than 8.0% 4. Pregnancy 5. Cirrhosis 6. Significant inflammation on liver biopsy - classified as a Brunt moderate or severe 7. Life expectancy of less than 2 years 8. Contraindications to MR scanning - pacemaker or metallic foreign body 9. Changes in the dose or initiation of lipid altering medication within the preceeding three months, such as statins, fibrates or systemic steroids 10. Use of n-3 PUFA supplements within the prior 4 months, an adequate washout period |
| Date of first enrolment | 12/01/2009 |
| Date of final enrolment | 01/12/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Nottingham University Hospital
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Sponsor information
University of Nottingham (UK)
University/education
University/education
Wolfson Digestive Diseases Centre
South Block, C-Floor
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
England
United Kingdom
| Website | http://www.nottingham.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
Charity
Association of Medical Research Charities (AMRC) - CORE
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
24/08/2016: No publications found, verifying study status with principal investigator
