Trial Outcomes & Findings for Treatment of Non Alcoholic Fatty Liver Disease With n-3 Fatty Acids (NCT NCT00760513)
NCT ID: NCT00760513
Last Updated: 2019-10-25
Results Overview
Percentage of liver fat was measured using magnetic resonance spectroscopy at baseline and end of study. High percentage values indicate a lot of liver fat (scale from 0 to 100%). Change in liver fat percentage represented the arithmetical difference between end of study liver fat percentage minus baseline measurement of liver fat percentage change in liver fat percentage was used to test whether the intervention decreased liver fat percentage. A negative change value in liver fat percentage indicates a response to therapy. A positive change value indicates no response to therapy.
COMPLETED
PHASE4
103 participants
Baseline and 18 months
2019-10-25
Participant Flow
Participant milestones
| Measure |
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)
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
52
|
|
Overall Study
COMPLETED
|
46
|
45
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
| Measure |
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)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
7
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Omega 3 Fatty Acid (Fish Oil)
n=51 Participants
OMACOR (alternative name: Lovaza) 4 grammes daily, oral capsule
|
Dummy Pill
n=52 Participants
4 grammes daily, oral capsule (olive oil)
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=51 Participants
|
0 Participants
n=52 Participants
|
0 Participants
n=103 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=51 Participants
|
46 Participants
n=52 Participants
|
93 Participants
n=103 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=51 Participants
|
6 Participants
n=52 Participants
|
10 Participants
n=103 Participants
|
|
Age, Continuous
|
48.6 years
STANDARD_DEVIATION 11.1 • n=51 Participants
|
54 years
STANDARD_DEVIATION 9.6 • n=52 Participants
|
51.3 years
STANDARD_DEVIATION 10.6 • n=103 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=51 Participants
|
17 Participants
n=52 Participants
|
43 Participants
n=103 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=51 Participants
|
35 Participants
n=52 Participants
|
60 Participants
n=103 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
51 Participants
n=51 Participants
|
52 Participants
n=52 Participants
|
103 Participants
n=103 Participants
|
PRIMARY outcome
Timeframe: Baseline and 18 monthsPercentage of liver fat was measured using magnetic resonance spectroscopy at baseline and end of study. High percentage values indicate a lot of liver fat (scale from 0 to 100%). Change in liver fat percentage represented the arithmetical difference between end of study liver fat percentage minus baseline measurement of liver fat percentage change in liver fat percentage was used to test whether the intervention decreased liver fat percentage. A negative change value in liver fat percentage indicates a response to therapy. A positive change value indicates no response to therapy.
Outcome measures
| Measure |
Omega 3 Fatty Acid (Fish Oil)
n=46 Participants
OMACOR (alternative name: Lovaza) 4 grammes daily, oral capsule
|
Dummy Pill
n=45 Participants
4 grammes daily, oral capsule (olive oil)
|
|---|---|---|
|
Percentage of Liver Fat
|
-7.9 percentage of liver fat
Standard Deviation 17.4
|
-4.6 percentage of liver fat
Standard Deviation 9.2
|
PRIMARY outcome
Timeframe: Baseline and 18 monthsPopulation: Participants with baseline and end of study data
The Liver Fibrosis Score is an algorithmically derived score of liver fibrosis comprising measurements of tissue matrix metalloproteinase-1 (TIMP-1), hyaluronic acid (HA) and the amino terminal end of procollagen III (PIIINP) (see Guha et al. in Reference section). The Score represents a number on a numerical scale from 0 to 20. High values of the score (measured in arbitrary units) indicate high probability of advanced liver fibrosis, low scores indicate low probability of advanced liver fibrosis. Change in Liver Fibrosis Score was used to test the intervention. Change in liver fibrosis score represented the change in measurement as calculated as the arithmetic difference between the end value minus the baseline value of the Liver Fibrosis Score. The change in Liver Fibrosis Score can therefore be negative (representing an improvement in liver fibrosis between baseline and end of study) or be positive, (representing a worsening a liver fibrosis between baseline and end of study.
Outcome measures
| Measure |
Omega 3 Fatty Acid (Fish Oil)
n=46 Participants
OMACOR (alternative name: Lovaza) 4 grammes daily, oral capsule
|
Dummy Pill
n=45 Participants
4 grammes daily, oral capsule (olive oil)
|
|---|---|---|
|
Liver Fibrosis Score
|
0.3 score on a scale
Standard Deviation 0.6
|
0.2 score on a scale
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: Baseline and 18 monthsPopulation: Participants with baseline and end of study data.
The NAFLD fibrosis score represented a validated algorithmically-derived measure of liver fibrosis as reported in Angulo et al (see reference section). The Score is derived from anthropometric and biochemical measurements in subjects. The NAFLD fibrosis score represents an arbitrary number with no units from -5.0 to +5.0. High positive NAFLD fibrosis scores indicate a high probability of advanced liver fibrosis. Negative scores represent a low probability of advanced liver fibrosis. The change in NAFLD fibrosis score (measured in arbitrary units) was used to test the effect of the intervention and represented the arithmetic difference in the end minus baseline measurements of this score. Thus, a negative change in the Score in the Table represented an improvement in liver fibrosis score between baseline and the end of the study. A positive change in the Score in the Table represented a worsening in liver fibrosis score between baseline and end of the study.
Outcome measures
| Measure |
Omega 3 Fatty Acid (Fish Oil)
n=46 Participants
OMACOR (alternative name: Lovaza) 4 grammes daily, oral capsule
|
Dummy Pill
n=45 Participants
4 grammes daily, oral capsule (olive oil)
|
|---|---|---|
|
NAFLD Fibrosis Score
|
0.8 score on a scale
Standard Deviation 0.9
|
0.8 score on a scale
Standard Deviation 0.7
|
Adverse Events
Omega 3 Fatty Acid (Fish Oil)
Dummy Pill
Serious adverse events
| Measure |
Omega 3 Fatty Acid (Fish Oil)
n=51 participants at risk
OMACOR (alternative name: Lovaza) 4 grammes daily, oral capsule
OMACOR: 4 grammes daily, oral capsule
|
Dummy Pill
n=52 participants at risk
4 grammes daily, oral capsule (olive oil)
OMACOR: 4 grammes daily, oral capsule
|
|---|---|---|
|
Gastrointestinal disorders
Anaemia and disorientation
|
2.0%
1/51 • 18 months
|
0.00%
0/52 • 18 months
|
|
Surgical and medical procedures
seminoma
|
0.00%
0/51 • 18 months
|
1.9%
1/52 • 18 months
|
|
Skin and subcutaneous tissue disorders
cellulitis on right lateral malleolus
|
2.0%
1/51 • 18 months
|
0.00%
0/52 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute asthma attack
|
0.00%
0/51 • 18 months
|
1.9%
1/52 • 18 months
|
|
Endocrine disorders
stabilisation of her diabetes
|
0.00%
0/51 • 18 months
|
1.9%
1/52 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
severe chest pain
|
2.0%
1/51 • 18 months
|
0.00%
0/52 • 18 months
|
|
Surgical and medical procedures
Laparoscopy and appendectomy
|
0.00%
0/51 • 18 months
|
1.9%
1/52 • 18 months
|
|
Cardiac disorders
chest pain radiating to the neck with tingling to left arm
|
0.00%
0/51 • 18 months
|
1.9%
1/52 • 18 months
|
|
Surgical and medical procedures
laparoscopic adhesiolysis
|
0.00%
0/51 • 18 months
|
1.9%
1/52 • 18 months
|
|
Surgical and medical procedures
elective hysterectomy
|
0.00%
0/51 • 18 months
|
1.9%
1/52 • 18 months
|
|
Surgical and medical procedures
removal of myxoma
|
0.00%
0/51 • 18 months
|
1.9%
1/52 • 18 months
|
|
Surgical and medical procedures
Tonsillectomy
|
2.0%
1/51 • 18 months
|
0.00%
0/52 • 18 months
|
Other adverse events
| Measure |
Omega 3 Fatty Acid (Fish Oil)
n=51 participants at risk
OMACOR (alternative name: Lovaza) 4 grammes daily, oral capsule
OMACOR: 4 grammes daily, oral capsule
|
Dummy Pill
n=52 participants at risk
4 grammes daily, oral capsule (olive oil)
OMACOR: 4 grammes daily, oral capsule
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
dermatological disorders
|
15.7%
8/51 • 18 months
|
17.3%
9/52 • 18 months
|
|
Gastrointestinal disorders
Nausea and vomitting
|
5.9%
3/51 • 18 months
|
7.7%
4/52 • 18 months
|
|
General disorders
accidental fall
|
0.00%
0/51 • 18 months
|
3.8%
2/52 • 18 months
|
|
General disorders
achile's heel and foot problems
|
0.00%
0/51 • 18 months
|
3.8%
2/52 • 18 months
|
|
Blood and lymphatic system disorders
anaemia
|
3.9%
2/51 • 18 months
|
0.00%
0/52 • 18 months
|
|
General disorders
anxiety and depression
|
7.8%
4/51 • 18 months
|
3.8%
2/52 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
asthma and breathing
|
5.9%
3/51 • 18 months
|
0.00%
0/52 • 18 months
|
|
Musculoskeletal and connective tissue disorders
back pain and sciatica
|
5.9%
3/51 • 18 months
|
3.8%
2/52 • 18 months
|
|
Musculoskeletal and connective tissue disorders
carpal disorders
|
0.00%
0/51 • 18 months
|
1.9%
1/52 • 18 months
|
|
Renal and urinary disorders
urological disorders
|
9.8%
5/51 • 18 months
|
21.2%
11/52 • 18 months
|
|
Infections and infestations
chest infection
|
25.5%
13/51 • 18 months
|
7.7%
4/52 • 18 months
|
|
Cardiac disorders
chest pain and ecg alterations
|
9.8%
5/51 • 18 months
|
9.6%
5/52 • 18 months
|
|
General disorders
dental disorders
|
0.00%
0/51 • 18 months
|
3.8%
2/52 • 18 months
|
|
Gastrointestinal disorders
diarrhea
|
7.8%
4/51 • 18 months
|
11.5%
6/52 • 18 months
|
|
Metabolism and nutrition disorders
dyslipidaemia
|
2.0%
1/51 • 18 months
|
1.9%
1/52 • 18 months
|
|
General disorders
fall and fracture
|
2.0%
1/51 • 18 months
|
0.00%
0/52 • 18 months
|
|
Reproductive system and breast disorders
fertility problems
|
2.0%
1/51 • 18 months
|
0.00%
0/52 • 18 months
|
|
Musculoskeletal and connective tissue disorders
fibromyalgia
|
2.0%
1/51 • 18 months
|
0.00%
0/52 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
flu, cough and sore throat
|
25.5%
13/51 • 18 months
|
9.6%
5/52 • 18 months
|
|
General disorders
fluid retention and oedema
|
0.00%
0/51 • 18 months
|
3.8%
2/52 • 18 months
|
|
Gastrointestinal disorders
gastrointestinal disorder
|
11.8%
6/51 • 18 months
|
9.6%
5/52 • 18 months
|
|
Reproductive system and breast disorders
gynecological disorders
|
3.9%
2/51 • 18 months
|
1.9%
1/52 • 18 months
|
|
General disorders
headache and dizziness
|
11.8%
6/51 • 18 months
|
11.5%
6/52 • 18 months
|
|
Hepatobiliary disorders
hepatological disorder
|
0.00%
0/51 • 18 months
|
1.9%
1/52 • 18 months
|
|
Metabolism and nutrition disorders
hyperglycaemia & hypoglycaemia
|
2.0%
1/51 • 18 months
|
5.8%
3/52 • 18 months
|
|
General disorders
hypertension
|
9.8%
5/51 • 18 months
|
1.9%
1/52 • 18 months
|
|
General disorders
insomnia
|
2.0%
1/51 • 18 months
|
0.00%
0/52 • 18 months
|
|
Musculoskeletal and connective tissue disorders
joint pain
|
25.5%
13/51 • 18 months
|
21.2%
11/52 • 18 months
|
|
Musculoskeletal and connective tissue disorders
knee surgery
|
3.9%
2/51 • 18 months
|
0.00%
0/52 • 18 months
|
|
Hepatobiliary disorders
liver biopsy
|
2.0%
1/51 • 18 months
|
0.00%
0/52 • 18 months
|
|
Nervous system disorders
neurological disorders
|
2.0%
1/51 • 18 months
|
0.00%
0/52 • 18 months
|
|
Endocrine disorders
onset diabetes
|
3.9%
2/51 • 18 months
|
1.9%
1/52 • 18 months
|
|
Eye disorders
ophtalmological disorders
|
0.00%
0/51 • 18 months
|
11.5%
6/52 • 18 months
|
|
Musculoskeletal and connective tissue disorders
orthopedic disorder
|
0.00%
0/51 • 18 months
|
1.9%
1/52 • 18 months
|
|
Product Issues
other drug overdose
|
3.9%
2/51 • 18 months
|
0.00%
0/52 • 18 months
|
|
Product Issues
other drug reaction
|
9.8%
5/51 • 18 months
|
0.00%
0/52 • 18 months
|
|
Ear and labyrinth disorders
otolaryngological disorders
|
19.6%
10/51 • 18 months
|
5.8%
3/52 • 18 months
|
|
Reproductive system and breast disorders
pregnancy
|
2.0%
1/51 • 18 months
|
0.00%
0/52 • 18 months
|
|
Gastrointestinal disorders
proctological disorders
|
5.9%
3/51 • 18 months
|
5.8%
3/52 • 18 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place