Condition category
Digestive System
Date applied
19/05/2010
Date assigned
19/05/2010
Last edited
24/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Richard Johnston

ORCID ID

Contact details

Nottingham University Hospital
Wolfson Digestive Diseases Centre
C Floor
South Block QMC
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7156

Study information

Scientific title

The effect of n-3 polyunsaturated fatty acid (PUFA) supplementation in patients with steatosis due to non-alcoholic fatty liver disease

Acronym

Study hypothesis

Assess the effects of a 3 month PUFA supplementation versus placebo.

Ethics approval

Nottingham Research and Ethics Committee 1, 11/03/2008, ref: 08/H0403/14

Study design

Single centre randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Fructose, glucose

Primary outcome measures

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 trial start date

12/01/2009

Overall trial end date

01/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age greater than 18 years, either sex
2. Liver biopsy showing NAFLD

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 58; UK sample size: 58

Participant 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

Recruitment start date

12/01/2009

Recruitment end date

01/12/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nottingham University Hospital
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

Wolfson Digestive Diseases Centre
South Block
C-Floor
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/

Funders

Funder type

Charity

Funder name

Association of Medical Research Charities (AMRC) - CORE

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/08/2016: No publications found, verifying study status with principal investigator