Trial Outcomes & Findings for The Impact of Omega Three Fatty Acids on Vascular Function in HIV (NCT NCT01041521)
NCT ID: NCT01041521
Last Updated: 2020-02-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
129 participants
Primary outcome timeframe
24 months
Results posted on
2020-02-11
Participant Flow
12 participants were enrolled but the did not participate due to 1) declining to participate, 2) inability of study team to locate participant, or 3) moving out of state.
Participant milestones
| Measure |
Lovaza (Omega Three Fatty Acid)
Lovaza: Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 24 months
Other Names:
Lovaza was previously known as Omacor (omega-3-acid ethyl esters) capsules
|
Sugar Pill
Dietary Supplement: sugar pill
2 capsules given twice daily for 24 months
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
56
|
|
Overall Study
COMPLETED
|
44
|
40
|
|
Overall Study
NOT COMPLETED
|
17
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Impact of Omega Three Fatty Acids on Vascular Function in HIV
Baseline characteristics by cohort
| Measure |
Lovaza (Omega Three Fatty Acid)
n=61 Participants
Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks.
Other Names:
Lovaza was previously known as Omacor (omega-3-acid ethyl esters) capsules
Lovaza: Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 24 months
|
Sugar Pill
n=56 Participants
Dietary Supplement: sugar pill
2 capsules given twice daily Arms: sugar pill
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 9 • n=99 Participants
|
50 years
STANDARD_DEVIATION 9 • n=107 Participants
|
51 years
STANDARD_DEVIATION 9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
92 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=99 Participants
|
56 participants
n=107 Participants
|
117 participants
n=206 Participants
|
|
Current smoker
|
24 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
CD4+ cell count
|
652 cells/cubic mL
STANDARD_DEVIATION 394 • n=99 Participants
|
644 cells/cubic mL
STANDARD_DEVIATION 309 • n=107 Participants
|
648 cells/cubic mL
STANDARD_DEVIATION 354 • n=206 Participants
|
|
Undetectable HIV viral load
|
58 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
110 Participants
n=206 Participants
|
|
Body mass index (BMI)
|
28 kg/meters squared
STANDARD_DEVIATION 6 • n=99 Participants
|
28 kg/meters squared
STANDARD_DEVIATION 6 • n=107 Participants
|
28 kg/meters squared
STANDARD_DEVIATION 6 • n=206 Participants
|
PRIMARY outcome
Timeframe: 24 monthsOutcome measures
| Measure |
Lovaza (Omega Three Fatty Acid)
n=43 Participants
Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks.
Other Names:
Lovaza was previously known as Omacor (omega-3-acid ethyl esters) capsules
Lovaza: Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 24 months
|
Sugar Pill
n=40 Participants
Dietary Supplement: sugar pill
2 capsules given twice daily Arms: sugar pill
|
|---|---|---|
|
Triglyceride Level
|
130 mg/dL
Interval 100.0 to 166.0
|
159 mg/dL
Interval 118.0 to 233.0
|
SECONDARY outcome
Timeframe: 24 monthsCarotid-femoral pulse wave velocity is a measure of arterial stiffness, with lower values indicating less arterial stiffness.
Outcome measures
| Measure |
Lovaza (Omega Three Fatty Acid)
n=41 Participants
Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks.
Other Names:
Lovaza was previously known as Omacor (omega-3-acid ethyl esters) capsules
Lovaza: Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 24 months
|
Sugar Pill
n=40 Participants
Dietary Supplement: sugar pill
2 capsules given twice daily Arms: sugar pill
|
|---|---|---|
|
Vascular Function
|
833 m/s
Standard Deviation 238
|
832 m/s
Standard Deviation 152
|
Adverse Events
Lovaza (Omega Three Fatty Acid)
Serious events: 22 serious events
Other events: 27 other events
Deaths: 0 deaths
Sugar Pill
Serious events: 21 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lovaza (Omega Three Fatty Acid)
n=61 participants at risk
Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks.
Other Names:
Lovaza was previously known as Omacor (omega-3-acid ethyl esters) capsules
Lovaza: Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 24 months
|
Sugar Pill
n=56 participants at risk
Dietary Supplement: sugar pill
2 capsules given twice daily Arms: sugar pill
|
|---|---|---|
|
Gastrointestinal disorders
excessive burping/gas, reflux
|
3.3%
2/61 • Number of events 3
|
0.00%
0/56
|
|
Gastrointestinal disorders
nausea/vomiting
|
1.6%
1/61 • Number of events 1
|
3.6%
2/56 • Number of events 2
|
|
Vascular disorders
Leg swelling or edema
|
0.00%
0/61
|
3.6%
2/56 • Number of events 2
|
|
Nervous system disorders
dizziness
|
0.00%
0/61
|
1.8%
1/56 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
1/61 • Number of events 1
|
5.4%
3/56 • Number of events 3
|
|
Infections and infestations
sepsis
|
1.6%
1/61 • Number of events 2
|
0.00%
0/56
|
|
Respiratory, thoracic and mediastinal disorders
Pleural fluid
|
0.00%
0/61
|
3.6%
2/56 • Number of events 2
|
|
Nervous system disorders
stroke
|
1.6%
1/61 • Number of events 1
|
0.00%
0/56
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
8.2%
5/61 • Number of events 5
|
1.8%
1/56 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
asthma/shortness of breath
|
3.3%
2/61 • Number of events 2
|
1.8%
1/56 • Number of events 1
|
|
Cardiac disorders
heart failure
|
0.00%
0/61
|
5.4%
3/56 • Number of events 4
|
|
Cardiac disorders
myocardial infarction
|
1.6%
1/61 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
orthopedic surgery
|
1.6%
1/61 • Number of events 3
|
1.8%
1/56 • Number of events 1
|
|
Cardiac disorders
death
|
0.00%
0/61
|
1.8%
1/56 • Number of events 1
|
|
Cardiac disorders
chest pain
|
0.00%
0/61
|
5.4%
3/56 • Number of events 3
|
|
Endocrine disorders
diabetic incident
|
0.00%
0/61
|
3.6%
2/56 • Number of events 4
|
|
Gastrointestinal disorders
pancreatitis
|
0.00%
0/61
|
1.8%
1/56 • Number of events 1
|
|
Gastrointestinal disorders
diverticulitis
|
0.00%
0/61
|
1.8%
1/56 • Number of events 1
|
|
General disorders
elevated triglycerides
|
1.6%
1/61 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
|
Infections and infestations
Infection of urinary tract
|
3.3%
2/61 • Number of events 2
|
1.8%
1/56 • Number of events 1
|
|
Renal and urinary disorders
renal failure/elevated creatinine
|
0.00%
0/61
|
3.6%
2/56 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
joint pain
|
0.00%
0/61
|
3.6%
2/56 • Number of events 2
|
|
Gastrointestinal disorders
difficulty swallowing
|
0.00%
0/61
|
1.8%
1/56 • Number of events 1
|
|
Nervous system disorders
tension headache
|
1.6%
1/61 • Number of events 1
|
0.00%
0/56
|
|
Nervous system disorders
numbness
|
1.6%
1/61 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
|
Nervous system disorders
sciatic nerve/muscle spasm
|
0.00%
0/61
|
1.8%
1/56 • Number of events 1
|
|
Nervous system disorders
syncope
|
0.00%
0/61
|
1.8%
1/56 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
acute/chronic bronchitis
|
0.00%
0/61
|
1.8%
1/56 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
prostate resection due to prostate cancer
|
1.6%
1/61 • Number of events 1
|
0.00%
0/56
|
|
Nervous system disorders
concussion
|
1.6%
1/61 • Number of events 1
|
0.00%
0/56
|
|
Gastrointestinal disorders
epiglottitis
|
0.00%
0/61
|
1.8%
1/56 • Number of events 1
|
|
Nervous system disorders
confusion
|
0.00%
0/61
|
1.8%
1/56 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
cocaine-induced bronchospasm
|
0.00%
0/61
|
1.8%
1/56 • Number of events 1
|
|
General disorders
False positive TB test
|
1.6%
1/61 • Number of events 1
|
0.00%
0/56
|
|
General disorders
Pain
|
1.6%
1/61 • Number of events 1
|
0.00%
0/56
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lung cancer
|
0.00%
0/61
|
1.8%
1/56 • Number of events 1
|
|
Infections and infestations
viral gastroenteritis
|
1.6%
1/61 • Number of events 1
|
0.00%
0/56
|
|
General disorders
broken denture
|
0.00%
0/61
|
1.8%
1/56 • Number of events 1
|
|
Gastrointestinal disorders
hernia repair
|
1.6%
1/61 • Number of events 1
|
0.00%
0/56
|
|
Infections and infestations
Fever and cough
|
0.00%
0/61
|
1.8%
1/56 • Number of events 1
|
|
Endocrine disorders
hyperglycemia
|
1.6%
1/61 • Number of events 1
|
0.00%
0/56
|
|
Infections and infestations
liver infection
|
0.00%
0/61
|
1.8%
1/56 • Number of events 1
|
|
Renal and urinary disorders
nephrolithiasis
|
0.00%
0/61
|
1.8%
1/56 • Number of events 1
|
|
Cardiac disorders
cardiac bypass surgery
|
1.6%
1/61 • Number of events 1
|
0.00%
0/56
|
|
Infections and infestations
foot infection
|
1.6%
1/61 • Number of events 1
|
0.00%
0/56
|
|
Skin and subcutaneous tissue disorders
rash/eczema
|
0.00%
0/61
|
1.8%
1/56 • Number of events 1
|
Other adverse events
| Measure |
Lovaza (Omega Three Fatty Acid)
n=61 participants at risk
Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks.
Other Names:
Lovaza was previously known as Omacor (omega-3-acid ethyl esters) capsules
Lovaza: Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 24 months
|
Sugar Pill
n=56 participants at risk
Dietary Supplement: sugar pill
2 capsules given twice daily Arms: sugar pill
|
|---|---|---|
|
Gastrointestinal disorders
excessive gas / burping /bloating
|
14.8%
9/61 • Number of events 10
|
7.1%
4/56 • Number of events 4
|
|
Gastrointestinal disorders
abdominal pain
|
4.9%
3/61 • Number of events 3
|
0.00%
0/56
|
|
General disorders
body aches
|
1.6%
1/61 • Number of events 1
|
0.00%
0/56
|
|
Gastrointestinal disorders
Diarrhea or loose stools
|
13.1%
8/61 • Number of events 9
|
8.9%
5/56 • Number of events 5
|
|
Gastrointestinal disorders
elevated total bilirubin
|
0.00%
0/61
|
1.8%
1/56 • Number of events 1
|
|
Gastrointestinal disorders
nausea
|
9.8%
6/61 • Number of events 6
|
3.6%
2/56 • Number of events 2
|
|
Vascular disorders
leg swelling and edema
|
4.9%
3/61 • Number of events 4
|
3.6%
2/56 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
rash or hives
|
8.2%
5/61 • Number of events 5
|
7.1%
4/56 • Number of events 4
|
|
Gastrointestinal disorders
vomiting
|
1.6%
1/61 • Number of events 1
|
3.6%
2/56 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
asthma/pneumonia
|
1.6%
1/61 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
total body itching
|
0.00%
0/61
|
1.8%
1/56 • Number of events 1
|
|
General disorders
surgery (rectal/bladder, hernia)
|
1.6%
1/61 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
|
General disorders
body odor
|
0.00%
0/61
|
1.8%
1/56 • Number of events 1
|
|
General disorders
change in taste
|
1.6%
1/61 • Number of events 1
|
0.00%
0/56
|
|
General disorders
dehydration
|
1.6%
1/61 • Number of events 1
|
0.00%
0/56
|
|
Musculoskeletal and connective tissue disorders
pain
|
3.3%
2/61 • Number of events 2
|
0.00%
0/56
|
|
Nervous system disorders
concussion
|
0.00%
0/61
|
1.8%
1/56 • Number of events 1
|
|
Renal and urinary disorders
kidney stent
|
1.6%
1/61 • Number of events 1
|
0.00%
0/56
|
|
Musculoskeletal and connective tissue disorders
wrist sprain
|
0.00%
0/61
|
1.8%
1/56 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
0.00%
0/61
|
1.8%
1/56 • Number of events 1
|
|
Endocrine disorders
Hyperglycemia
|
1.6%
1/61 • Number of events 1
|
0.00%
0/56
|
|
Vascular disorders
hypertension
|
0.00%
0/61
|
1.8%
1/56 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
sacral fracture
|
0.00%
0/61
|
1.8%
1/56 • Number of events 1
|
|
General disorders
fatigue
|
0.00%
0/61
|
1.8%
1/56 • Number of events 1
|
|
Metabolism and nutrition disorders
increased abdominal fat
|
1.6%
1/61 • Number of events 1
|
0.00%
0/56
|
|
Nervous system disorders
fall with loss of consciousness
|
0.00%
0/61
|
1.8%
1/56 • Number of events 1
|
|
General disorders
fever
|
1.6%
1/61 • Number of events 1
|
0.00%
0/56
|
|
Ear and labyrinth disorders
fluid in ears
|
1.6%
1/61 • Number of events 1
|
0.00%
0/56
|
|
Cardiac disorders
congestive heart failure
|
1.6%
1/61 • Number of events 1
|
0.00%
0/56
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place