Treatment of Non Alcoholic Fatty Liver Disease With n-3 Fatty Acids
NCT ID: NCT00760513
Last Updated: 2019-10-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
103 participants
INTERVENTIONAL
2009-11-01
2018-11-29
Brief Summary
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In NAFLD patients, the investigators will test the hypothesis that treatment with long chain n-3 fatty acid supplementation for 18 months favourably influences bio-markers for NAFLD and risk factors for cardiovascular disease and type 2 diabetes.
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Detailed Description
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Purpose and design
We are asking the research question ' Does treatment with purified long chain n-3 fatty acids (purified fish oil) improve non alcoholic fatty liver disease and risk factors for heart disease and type 2 (adult) diabetes that are strongly linked to this liver condition?'
Presently there is no treatment for this liver condition. Research evidence suggests that purified long chain n-3 fatty acids might be beneficial for this condition.
To address this research question we want to undertake a randomised double blind placebo controlled trial recruiting people who have been diagnosed with a liver biopsy as having the liver condition.
A protocol change that were approved during in the course of the study in October 2011.
In the protocol, we have deleted information regarding liver biopsy that was to be offered at the end of the study.
Having collated volunteer opinion and local consultant opinion, whereas a high proportion of volunteers were happy to undergo a follow up liver biopsy, our local hepatologists now consider that in 2011, the small risk of morbidity and mortality of volunteers undergoing liver biopsy is unacceptable, within the context of a research study. Their opinions have changed since 2008 when the initial LREC approval was granted.
Liver biopsy was always an optional extra and would only have been undertaken in a subgroup of the volunteers. Therefore, removal of liver biopsy from the protocol does not affect the validity of the study to test effects of the n-3 fatty acid intervention on biomarkers and liver fat in people with non alcoholic fatty liver disease.
Besides removal of liver biopsy from the protocol, we have clarified in the protocol, the end points of the study and numbers randomised to either n-3 fatty acid or placebo (n=100, as always intended). We have also made it clear in the amendment that measurement of liver fat is also a primary outcome of the study. (We already have permission to undertake this test but it was uncertain when the study was approved that we would have sufficient funding for this expensive test and it was originally not a primary outcome).
We have therefore added a power calculation (and cited the relevant literature) to show that with a sample size of n=100 people, based upon the known treatment effects of n-3 fatty acids on liver fat, we have acceptable power to detect the predicted decrease in this outcome with treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Omega 3 fatty acid (fish oil)
OMACOR (alternative name: Lovaza) 4 grammes daily, oral capsule
OMACOR
4 grammes daily, oral capsule
dummy pill
4 grammes daily, oral capsule (olive oil)
Placebo oral capsule
4 grammes daily, oral capsule (olive oil)
Interventions
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OMACOR
4 grammes daily, oral capsule
Placebo oral capsule
4 grammes daily, oral capsule (olive oil)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Steatosis diagnosed by ultrasound, CT or magnetic resonance imaging who also have either diabetes and/or features of the metabolic syndrome, without evidence of known aetiological factors for underlying liver disease (e.g. exclusion of hepatitis A, B \& C, primary biliary cirrhosis, autoimmune hepatitis, haemochromatosis).
Liver biopsy or liver scan will be within 3 years of recruitment to the study. Age: men \& women \>18 years. Alcohol consumption \<35 units / week for women \<50 units / week for men).
Exclusion Criteria
18 Years
75 Years
ALL
No
Sponsors
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National Institute for Health Research, United Kingdom
OTHER_GOV
University Hospital Southampton NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Christopher D Byrne, MBBCh PhD
Role: PRINCIPAL_INVESTIGATOR
University of Southampton, UK
Locations
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Southamption General Hospital
Southampton, Hants, United Kingdom
Countries
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References
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Scorletti E, Bhatia L, McCormick KG, Clough GF, Nash K, Calder PC, Byrne CD; WELCOME Trial Investigators. Design and rationale of the WELCOME trial: A randomised, placebo controlled study to test the efficacy of purified long chainomega-3 fatty acid treatment in non-alcoholic fatty liver disease [corrected]. Contemp Clin Trials. 2014 Mar;37(2):301-11. doi: 10.1016/j.cct.2014.02.002. Epub 2014 Feb 18.
Guha IN, Parkes J, Roderick P, Chattopadhyay D, Cross R, Harris S, Kaye P, Burt AD, Ryder SD, Aithal GP, Day CP, Rosenberg WM. Noninvasive markers of fibrosis in nonalcoholic fatty liver disease: Validating the European Liver Fibrosis Panel and exploring simple markers. Hepatology. 2008 Feb;47(2):455-60. doi: 10.1002/hep.21984.
Angulo P, Hui JM, Marchesini G, Bugianesi E, George J, Farrell GC, Enders F, Saksena S, Burt AD, Bida JP, Lindor K, Sanderson SO, Lenzi M, Adams LA, Kench J, Therneau TM, Day CP. The NAFLD fibrosis score: a noninvasive system that identifies liver fibrosis in patients with NAFLD. Hepatology. 2007 Apr;45(4):846-54. doi: 10.1002/hep.21496.
Scorletti E, Bhatia L, McCormick KG, Clough GF, Nash K, Hodson L, Moyses HE, Calder PC, Byrne CD; WELCOME Study. Effects of purified eicosapentaenoic and docosahexaenoic acids in nonalcoholic fatty liver disease: results from the Welcome* study. Hepatology. 2014 Oct;60(4):1211-21. doi: 10.1002/hep.27289.
Hodson L, Bhatia L, Scorletti E, Smith DE, Jackson NC, Shojaee-Moradie F, Umpleby M, Calder PC, Byrne CD. Docosahexaenoic acid enrichment in NAFLD is associated with improvements in hepatic metabolism and hepatic insulin sensitivity: a pilot study. Eur J Clin Nutr. 2017 Aug;71(8):973-979. doi: 10.1038/ejcn.2017.9. Epub 2017 Mar 15.
Clough GF, McCormick KG, Scorletti E, Bhatia L, Calder PC, Griffin MJ, Byrne CD. Higher body fat percentage is associated with enhanced temperature perception in NAFLD: results from the randomised Wessex Evaluation of fatty Liver and Cardiovascular markers in NAFLD with OMacor thErapy trial (WELCOME) trial. Diabetologia. 2016 Jul;59(7):1422-1429. doi: 10.1007/s00125-016-3966-8. Epub 2016 Apr 22.
Bhatia L, Scorletti E, Curzen N, Clough GF, Calder PC, Byrne CD. Improvement in non-alcoholic fatty liver disease severity is associated with a reduction in carotid intima-media thickness progression. Atherosclerosis. 2016 Mar;246:13-20. doi: 10.1016/j.atherosclerosis.2015.12.028. Epub 2015 Dec 24.
Byrne CD, Targher G. Time to Replace Assessment of Liver Histology With MR-Based Imaging Tests to Assess Efficacy of Interventions for Nonalcoholic Fatty Liver Disease. Gastroenterology. 2016 Jan;150(1):7-10. doi: 10.1053/j.gastro.2015.11.016. Epub 2015 Nov 18. No abstract available.
Scorletti E, West AL, Bhatia L, Hoile SP, McCormick KG, Burdge GC, Lillycrop KA, Clough GF, Calder PC, Byrne CD. Treating liver fat and serum triglyceride levels in NAFLD, effects of PNPLA3 and TM6SF2 genotypes: Results from the WELCOME trial. J Hepatol. 2015 Dec;63(6):1476-83. doi: 10.1016/j.jhep.2015.07.036. Epub 2015 Aug 10.
McCormick KG, Scorletti E, Bhatia L, Calder PC, Griffin MJ, Clough GF, Byrne CD. Impact of high dose n-3 polyunsaturated fatty acid treatment on measures of microvascular function and vibration perception in non-alcoholic fatty liver disease: results from the randomised WELCOME trial. Diabetologia. 2015 Aug;58(8):1916-25. doi: 10.1007/s00125-015-3628-2. Epub 2015 May 29.
Byrne CD, Targher G. Ectopic fat, insulin resistance, and nonalcoholic fatty liver disease: implications for cardiovascular disease. Arterioscler Thromb Vasc Biol. 2014 Jun;34(6):1155-61. doi: 10.1161/ATVBAHA.114.303034. Epub 2014 Apr 17.
Targher G, Byrne CD. Clinical Review: Nonalcoholic fatty liver disease: a novel cardiometabolic risk factor for type 2 diabetes and its complications. J Clin Endocrinol Metab. 2013 Feb;98(2):483-95. doi: 10.1210/jc.2012-3093. Epub 2013 Jan 4.
Other Identifiers
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08/H0502/165
Identifier Type: OTHER
Identifier Source: secondary_id
25-12-59. (R&D: RHM MED 0836)
Identifier Type: -
Identifier Source: org_study_id
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